NCT05624996ClinicalTrials.gov

Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 3474 participants recherchés477 sites2 pays

Catégories

Oncologie77%Respiratoire17%Immunologie et rhumatologie6%

Enregistré dans 1 registre

ClinicalTrials.govNCT05624996Ouvrir cette fiche sur ClinicalTrials.govSynchronisé le mois dernier

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-11-22; recorded start 2023-07-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 49 other studies in this databaseCounted from the lead sponsor named in the record (NRG Oncology)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: other.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 477 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 474 participants (target), run at 477 sites, across 2 countries.

How this score is built

Enrolment26/40
474 participants (target)
Site count25/25
477 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 101 months
Sponsor scale6/10
NRG Oncology has led 49 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy \[IGRT\] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation therapy to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation therapy that creates a picture of the tumor to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Usual chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds. Cisplatin works by killing, stopping, or slowing the growth of tumor cells. Carboplatin works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells as well. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Immunotherapy with durvalumab can induce changes in the body's immune system and can interfere with the ability of tumor cells to grow and spread. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Adding SBRT to the usual treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with locally-advanced non-small cell lung cancer than giving the usual treatment alone.

PRIMARY OBJECTIVES: I. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after image guided, motion-managed stereotactic body radiation therapy (SBRT) to the primary tumor followed by conventionally fractionated radiotherapy to nodal metastases (Arm 2) both given with concurrent platinum-based chemotherapy. II. To compare progression-free survival between the experimental arm (Arm 2) and control arm (Arm 1). SECONDARY OBJECTIVES: I. To compare objective response rate (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) between the experimental arm and control arm. II. To compare the rate of local control between the experimental arm and control arm. III. To compare patterns of failure (primary, locoregional, or distant) between the experimental arm and control arm. IV. To compare changes in pulmonary function (forced expiratory volume in 1 second \[FEV1\] and diffusion capacity of the lung for carbon monoxide \[DLCO\] assessed at randomization and at 6- and 12- months following completion of radiation therapy) between the experimental arm and control arm. V. To compare changes in quality of life and patient-reported outcomes assessed from pre-treatment to 3 months following radiation therapy of each treatment arm. VI. To determine acute and late toxicity profiles of each treatment arm as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5. EXPLORATORY OBJECTIVES: I. To characterize and compare longitudinal quality of life and patient-reported outcomes of each treatment arm. II. To collect biospecimens at baseline, after SBRT (for Arm 2 patients), during last 2 weeks of chemoradiation, and after first dose of consolidation therapy, to allow for future analyses. III. To collect 4-dimensional (4D) computed tomography (CT) planning scans and radiation dose to calculate regional lung ventilation and explore pre-treatment 4D-CT based ventilation to predict pulmonary toxicity. IV. To characterize clinical outcomes, toxicities and changes in pulmonary function and quality of life among patients receiving proton and photon radiotherapy. V. To develop and characterize a machine learning/artificial intelligence algorithm for radiotherapy planning and/or quality assurance. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo conventional IGRT and receive usual care chemotherapy consisting of paclitaxel intravenously (IV) followed by carboplatin IV weekly (Q7D) during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or positron emission tomography (PET)/CT during follow-up. ARM II: Patients undergo SBRT and conventional IGRT and then receive standard-of-care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up. Patients are followed up every 3 months for 1 year, every 6 months during years 2 and 3, and then yearly after that for the duration of the study.

Affections

Locally Advanced Lung Non-Small Cell Carcinoma
Stage IIB Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer \[AJCC\] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration * Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal, supraclavicular/scalene) * Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible * Patients who refuse surgery, in addition to those who are technically unresectable or medically inoperable, are eligible. * Patients with separate tumor nodules in the same lobe of the primary tumor are eligible * The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments: * History/physical examination prior to registration; * Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration; * CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET/CT may be used if the CT portion is of identical diagnostic quality as achieved in a stand-alone CT * No evidence of distant metastases based on FDG PET/CT scan obtained within 60 days of registration * Primary tumor =\< 7 cm * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy * Creatinine clearance \>= 25 mL/min by the Cockcroft-Gault (C-G) equation * Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion * If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: * When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; * Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible * Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR/ALK/other driver mutation at the time of registration are eligible, and these patients can be treated with consolidation systemic therapy at the discretion of the treating physician * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Negative pregnancy test =\< 14 days prior to registration for participants of childbearing potential * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information Exclusion Criteria: * Prior radiotherapy to the study cancer (local recurrence). Prior radiotherapy for a different cancer/condition to the region of the study cancer that would result in overlap of radiation therapy fields that is determined by the treating physician to impede the treatment of the study malignancy * Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required, but pathologic confirmation of involvement is not mandated * Centrally located primary tumor \< 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation fields. This does not include proximity to involved segmental and subsegmental lymph nodes (levels 13 and 14) that would not result in overlap of dose to the proximal bronchial tree or esophagus. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi) * Participants who are pregnant or unwilling to discontinue nursing * Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe required after the final dose of the selected systemic therapy regimen, because the treatment in this study may be significantly teratogenic

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	474 participants recherchés

Promoteur et collaborateurs

NRG Oncology Promoteur

Groupes et interventions

Arm I (image guided RT, chemotherapy, immunotherapy)ACTIVE_COMPARATOR
Patients undergo conventional IGRT and receive usual care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up.
Arm II (SBRT, image guided RT, chemotherapy, immunotherapy)EXPERIMENTAL
Patients undergo SBRT and conventional IGRT and then receive standard-of-care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up.

Interventions

Médicament Carboplatin
Given IV
Médicament Cisplatin
Given IV
Intervention Computed Tomography
Undergo CT and/or PET/CT
Produit biologique Durvalumab
Given IV
Médicament Etoposide
Given IV
Radiothérapie Image Guided Radiation Therapy
Undergo IGRT
Médicament Nab-paclitaxel
Given IV
Médicament Osimertinib
Given PO
Médicament Paclitaxel
Given IV
Médicament Pemetrexed
Given IV
Intervention Positron Emission Tomography
Undergo PET/CT
Autre Questionnaire Administration
Ancillary studies
Radiothérapie Stereotactic Body Radiation Therapy
Undergo SBRT

Critères de jugement

Critère de jugement principal
Overall survival (OS)
Non-inferiority (NI) between arm 2 and arm 1 (reference level) will be evaluated by comparing the upper bound of the 95% confidence interval for the hazard ratio to the pre-specified NI margin. NI of arm 2 will be concluded if the upper bound of the confidence interval is equal to, or falls below, the pre-specified margin at the final analysis. When evaluating the NI of arm 2 in OS, a Cox proportional hazards (PH) model stratified by stratification factors will be used to compute the hazard ratio and associated 95% confidence interval (CI). OS rates will be estimated using the Kaplan-Meier method. If the NI of arm 2 in OS is demonstrated, the superiority of arm 1 in OS will be tested at 1-sided significance level of 0.025 using a stratified log-rank test by adjusting for stratification factors.
Délai Time between date of randomization and date of death due to any cause, assessed up to 8 years
Critère de jugement principal
Progression-free survival (PFS)
The PFS analysis will be conducted using the same methods and stratification factors as the OS analysis. The superiority of arm 2 in PFS will be tested at 1-sided significance level of 0.025 using a stratified log-rank test by adjusting for stratification factors. In the event that the NI of OS is not established, statistical inference of PFS will be considered exploratory in nature only. A Cox PH model stratified by stratification factors will be used to compute the hazard ratio and associated 95% CI.
Délai Time between date of randomization and first date of documented progression or death due to any cause, assessed up to 8 years
Critère de jugement secondaire
Objective response rate (ORR)
ORR (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR) and will be based on all randomized patients who have measurable disease. Therefore, data obtained up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR. The ORR will be compared between arm 2 versus arm 1 using a Fisher's exact test. A binary response variable for ORR will be used for the analysis with the categories of CR and PR versus stable disease, progressive disease and inevaluable.
Délai Up to 8 years
Critère de jugement secondaire
Time to progression
Local control also known as time to progression will be defined as freedom from local progression, in which a failure is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria. Local control will be analyzed as competing risks data based on cause-specific hazards approaches, where deaths without local failure will be considered as a competing event and analyzed as "censoring" of local failure. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.
Délai Up to 8 years
Critère de jugement secondaire
Time to primary, locoregional, or distant failure
Competing risks analysis will be used to analyze times to primary failure, locoregional failure and distant failure as the first failure. Competing events include primary failure, locoregional failure, distant failure and deaths without any failures. Rates at various timepoints (i.e., every 6 months after randomization) for each arm will be estimated using the cumulative incidence function. The associated 95% CI will be calculated using the Delta method and based on a log-log transformation applied on the estimated cumulative incidence functions. Statistical inferences of the development of each failure between arms will be based on cause-specific hazards using the log-rank test and Cox proportional hazard model. In addition, Gray's test and the Fine-Gray model will also be used to provide statistical inferences between arms based on cumulative incidence functions and subdistribution hazards.
Délai Up to 8 years
Critère de jugement secondaire
Changes in pulmonary function
Includes forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO). Changes in pulmonary function (FEV1 and DLCO) will be summarized with descriptive statistics, and compared with Wilcoxon rank-sum test. The descriptive statistics of changes in FEV1 and diffusion capacity before and after treatment will be reported by treatment arm and by response categories (complete response; partial response; stable disease; progressive disease). Linear regression will be used to model changes with adjustment for treatment arms and possibly other baseline covariates, if applicable. The grade 3-5 NRG Oncology Pulmonary Toxicity Scale for changes will be reported with the frequency and grade by arm. Logistic regression will be used to model the distribution of the NRG Oncology Pulmonary Toxicity Scale by arms with and without adjustment for covariates.
Délai From randomization to 6 months or 12 months
Critère de jugement secondaire
Patient reported outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Adverse events will also be assessed using PRO-CTCAE items. The PRO-CTCAE is a patient-reported outcome measurement system developed to characterize the frequency, severity, and interference of symptomatic treatment toxicities. Items are scored on a Likert scale. For each symptom and each domain (i.e., frequency, severity, and interference), counts and frequencies will be summarized for the worst score experienced by the patient by the treatment arm. In addition, a composite grading algorithm (Basch 2021) will be used to derive a single numerical grade for each adverse event scored using PRO-CTCAE. PRO-CTCAE, the frequency of acute grade \>= 3 patient-reported toxicity will be compared to the corresponding rate of clinician-scored toxicity using a chi-square test or Fisher exact test, as appropriate. Distributions of clinician-reported and patient-reported adverse events will also be compared across study arms.
Délai At 3, 12, and 24 months
Critère de jugement secondaire
Functional Assessment of Cancer Therapy Lung (FACT-L) and Trial Outcome Index (TOI)
FACT-L and TOI is a measure that sums the functional well-being (FWB - 7 items), physical well-being (PWB - 7), and the lung cancer subscale (LCS - 9 items) of FACT-L. Questionnaire trial outcome index deterioration rates at 3 months and associated 95% confidence interval will be calculated for each treatment group, based on all randomized subjects. In addition, to explore if higher QOL scores will be maintained at 12 and 24 months from the end of radiotherapy as well, longitudinal data analysis will also be performed to characterize the trend of scores over time across the two treatment groups using hierarchical formulation of the linear mixed model. The Clopper-Pearson method will be used for calculating 95% CI. The deterioration rates of each arm will also be compared using Cochran-Mantel-Haenszel Test, stratified by PD-L1 expression and T-stage.
Délai At 3, 12, and 24 months
Critère de jugement secondaire
European Quality of Life Five Dimension (EQ-5D) scale
Subjects' overall health state on a visual analog scale (EQ-VAS) at each assessment time point will be summarized using descriptive statistics by treatment group, as randomized. Proportion of subjects reporting problems for the five EQ-5D dimensions at each assessment time point will be summarized by level of problem and by treatment group, as randomized. Percentages will be based on number subjects assessed at assessment time point.
Délai At 3, 12, and 24 months
Critère de jugement secondaire
Incidence of adverse events
For each patient, the maximum severity reported will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. Treatment-related adverse events using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) will be presented in statistical analysis reports/publications in CTCAE version 5. Adverse event rates will be reported with the frequency and severity (e.g., type, grade, and attribution) by arm.
Délai Up to 8 years
Autre critère de jugement
Clinical outcomes
Descriptive analyses will be reported, based on corresponding analysis plans within patients who actually receive proton and photon radiotherapy (e.g., per-protocol population), respectively.
Délai Up to 8 years
Autre critère de jugement
Functional mean lung dose
Collection of 4-dimensional (4D) computed tomography (CT) planning CTs and calculation of radiation dose to regional lung ventilation will be performed among randomized patients with 4D CT planning CTs. To evaluate functional dose metrics, ventilation maps will be registered to the average 4DCT reference frame. Functional dose metrics and standard dose metrics will be calculated and evaluated. Functional mean lung dose will be defined as the mean dose delivered to functional lung. Dose to total lung and dose to functional lung will then be correlated with pulmonary toxicity including grade 2 or higher radiation pneumonitis or any grade 3 or higher cough, dyspnea, hypoxia or respiratory failure. Logistic regression models will be used to explore the correlation between pulmonary toxicity and functional mean lung dose.
Délai Up to 8 years
Autre critère de jugement
Incidence of toxicities
Descriptive analyses will be reported, based on corresponding analysis plans within patients who actually receive proton and photon radiotherapy (e.g., per-protocol population), respectively.
Délai Up to 8 years
Autre critère de jugement
Changes in pulmonary function
Descriptive analyses will be reported, based on corresponding analysis plans within patients who actually receive proton and photon radiotherapy (e.g., per-protocol population), respectively.
Délai Up to 8 years
Autre critère de jugement
Changes in quality of life
Descriptive analyses will be reported, based on corresponding analysis plans within patients who actually receive proton and photon radiotherapy (e.g., per-protocol population), respectively.
Délai Up to 8 years
Autre critère de jugement
Development and characterization of a machine learning/artificial intelligence (AI) algorithm for radiotherapy planning and/or quality assurance
Assessment will focus on four key areas: tumor volume contouring score, organs-at-risk contouring score, tumor volume dose-volume analysis score, and organs-at-risk dose-volume analysis score. Each area will be scored as per protocol: acceptable variation, unacceptable variation, or not evaluable. Cases deemed not evaluable will be considered as such, regardless of the reviewer. The scores generated by the AI algorithm will be compared with those from radiation oncologists, ensuring the AI algorithm adheres to the contours. The sensitivity of the AI algorithm, indicating its ability to detect deviations from the protocol, will be calculated. The AI algorithm will be refined until its sensitivity exceeds 95%. Inter-rater reliability between the AI algorithm and the radiation oncologists will be assessed using Cohen's κ. Concordance and discordance frequencies will also be recorded.
Délai Up to 8 years
Autre critère de jugement
Treatment effect and confidence intervals by sex
Délai Up to 8 years
Autre critère de jugement
Treatment effect and confidence intervals by race
Délai Up to 8 years
Autre critère de jugement
Treatment effect and confidence intervals by ethnicity
Délai Up to 8 years

Dates

Dates
Date de début	12 juillet 2023 (réelle)
Achèvement principal	15 octobre 2031 (estimée)
Achèvement	15 octobre 2036 (estimée)
Première publication	22 novembre 2022 (réelle)
Dernière mise à jour	17 août 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	août 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

446 sites sont en recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
Ottawa Hospital and Cancer Center-General Campus	Ottawa	Ontario	Suspendu

United States

United States
Établissement	Ville	État ou région	Statut
Cleveland Clinic Akron General	Akron	Ohio	En recrutement
Atrium Health Stanly/LCI-Albemarle	Albemarle	North Carolina	En recrutement
Presbyterian Kaseman Hospital	Albuquerque	New Mexico	Actif, sans recrutement
University of New Mexico Cancer Center	Albuquerque	New Mexico	En recrutement
Alton Memorial Hospital	Alton	Illinois	Actif, sans recrutement
Mary Greeley Medical Center	Ames	Iowa	En recrutement
McFarland Clinic - Ames	Ames	Iowa	En recrutement
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	En recrutement
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	En recrutement
Luminis Health Anne Arundel Medical Center	Annapolis	Maryland	Actif, sans recrutement
Langlade Hospital and Cancer Center	Antigo	Wisconsin	En recrutement
Northwest Wisconsin Cancer Center	Ashland	Wisconsin	En recrutement
Duluth Clinic Ashland	Ashland	Wisconsin	En recrutement
Emory Saint Joseph's Hospital	Atlanta	Georgia	En recrutement
Grady Health System	Atlanta	Georgia	En recrutement
Emory Proton Therapy Center	Atlanta	Georgia	En recrutement
Emory University Hospital Midtown	Atlanta	Georgia	En recrutement
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	En recrutement
Augusta University Medical Center	Augusta	Georgia	En recrutement
UCHealth University of Colorado Hospital	Aurora	Colorado	En recrutement
Rush-Copley Medical Center	Aurora	Illinois	En recrutement
Advocate Outpatient Center - Aurora	Aurora	Illinois	En recrutement
WellStar Cobb Hospital	Austell	Georgia	En recrutement
UH Seidman Cancer Center at UH Avon Health Center	Avon	Ohio	En recrutement
AIS Cancer Center at San Joaquin Community Hospital	Bakersfield	California	En recrutement
Sinai Hospital of Baltimore	Baltimore	Maryland	En recrutement
Greater Baltimore Medical Center	Baltimore	Maryland	En recrutement
Advocate Good Shepherd Hospital	Barrington	Illinois	En recrutement
Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	En recrutement
Wilmot Cancer Center at Batavia	Batavia	New York	Suspendu
McLaren Cancer Institute-Bay City	Bay City	Michigan	En recrutement
Bay Pines VA Healthcare System	Bay Pines	Florida	En recrutement
Northwell Health Imbert Cancer Center	Bay Shore	New York	En recrutement
UHHS-Chagrin Highlands Medical Center	Beachwood	Ohio	En recrutement
Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	En recrutement
Central Vermont Medical Center/National Life Cancer Treatment	Berlin Corners	Vermont	En recrutement
Billings Clinic Cancer Center	Billings	Montana	En recrutement
The Kirklin Clinic at Acton Road	Birmingham	Alabama	En recrutement
University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	En recrutement
Sanford Bismarck Medical Center	Bismarck	North Dakota	En recrutement
OSF Saint Joseph Medical Center	Bloomington	Illinois	En recrutement
Illinois CancerCare-Bloomington	Bloomington	Illinois	En recrutement
Saint Joseph's/Candler - Bluffton Campus	Bluffton	South Carolina	En recrutement
Bozeman Health Deaconess Hospital	Bozeman	Montana	En recrutement
Essentia Health Saint Joseph's Medical Center	Brainerd	Minnesota	En recrutement
Trinity Health IHA Medical Group Hematology Oncology - Brighton	Brighton	Michigan	En recrutement
Trinity Health Medical Center - Brighton	Brighton	Michigan	En recrutement
Henry Ford Cancer Institute-Downriver	Brownstown	Michigan	En recrutement
Mills-Peninsula Medical Center	Burlingame	California	En recrutement

427 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05624996