NCT07097142ClinicalTrials.gov

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study

The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)

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

Contacter cette étude

En bref

Phase 3486 participants recherchés211 sites1 pays

Catégories

Oncologie71%Néphrologie et urologie26%Obstétrique et gynécologie3%

Enregistré dans 1 registre

ClinicalTrials.govNCT07097142Ouvrir cette fiche sur ClinicalTrials.govSynchronisé le mois dernier

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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 2025-07-31; recorded start 2025-10-07
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: 211 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: 486 participants (target), run at 211 sites.

How this score is built

Enrolment26/40
486 participants (target)
Site count25/25
211 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 57 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 decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.

PRIMARY OBJECTIVE: I. Demonstrate non-inferiority of ultra-hypofractionated (stereotactic body radiation therapy \[SBRT\]) compared to hypofractionated radiation therapy (RT) with a 10% non-inferiority margin (from 50% to 40%) in the rate of bladder-intact event-free survival (BI-EFS) at 3 years (corresponding to a hazard ratio \< 1.32). SECONDARY OBJECTIVES: I. Compare the rates of urinary and bowel toxicity, patient-reported outcomes (PRO), event-free survival (EFS), metastasis-free survival (MFS), and overall survival (OS) between the two treatment arms. II. Compare and evaluate symptomatic adverse events and quality of life measures that are most meaningful to patients. III. Evaluate circulating tumor deoxyribonucleic acid (ctDNA) as a biomarker to determine whether it is predictive of disease recurrence and as a secondary outcome variable. EXPLORATORY OBJECTIVES: I. Evaluate ctDNA, tissue-free minimal residual disease (tfMRD) and urine tumor DNA (utDNA) as biomarkers for predicting recurrence. II. Evaluate tfMRD, obtained at the time of progression, to determine if it captures the presence of disease. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive hypofractionated radiation therapy (RT) once daily (QD), Monday to Friday, for 20 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin intravenously (IV) weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and fluorouracil (5 FU), over 120 hours on days 1-5 and 22-26. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) or fluorodeoxyglucose (FDG) positron emission tomography (PET) throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up. ARM II: Patients receive ultra-hypofractionated RT QD, no more than twice weekly, for 5 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up. After completion of study treatment, patients are followed up at week 16, every 3 months for 3 years then every 6 months to year 5.

Affections

Muscle Invasive Bladder Urothelial Carcinoma
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder 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: * Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization. * Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible * Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection * Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fluorodeoxyglucose (FDG) PET imaging is acceptable for radiological staging * If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT / MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement prior to randomization * No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy * No definitive clinical or radiologic evidence of metastatic disease * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy * Age ≥ 18 * Zubrod performance status of ≤ 2 * Not pregnant and not nursing * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\]) ≥ 8.0 g/dl is acceptable) * Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula * Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN * All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization * For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization * Must not have had prior pelvic radiation * New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.) * No active infection requiring IV antibiotics * Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified

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	486 participants recherchés

Promoteur et collaborateurs

NRG Oncology Promoteur

Groupes et interventions

Arm I (hypofractionated radiation therapy)ACTIVE_COMPARATOR
Patients receive hypofractionated RT QD, Monday to Friday, for 20 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up.
Arm II (Ultrahypofractionated radiation therapy)EXPERIMENTAL
Patients receive ultra-hypofractionated RT QD, no more than twice weekly, for 5 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up.

Interventions

Intervention Biospecimen Collection
Undergo blood, tissue, and urine sample collection
Médicament Cisplatin
Given IV
Intervention Computed Tomography
Undergo CT scan
Médicament Fluorouracil
Given IV
Médicament Gemcitabine
Given IV
Radiothérapie Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Intervention Magnetic Resonance Imaging
Undergo MRI
Médicament Mitomycin
Given IV
Intervention Positron Emission Tomography
Undergo PET scan
Autre Survey Administration
Ancillary studies
Radiothérapie Ultrahypofractionated Radiation Therapy
Undergo ultrahypofractionated radiation therapy.

Critères de jugement

Critère de jugement principal
Bladder-intact event-free survival (BI-EFS)
Defined as histologically proven presence of muscle invasive bladder cancer (MIBC), radiographic evidence of nodal or metastatic disease, performance of radical cystectomy, or death from any cause. Time to event will be calculated from the date of randomization. BI-EFS will be estimated in the two treatment groups using the Kaplan-Meier method and the hazard ratio between ultra-hypofractionation and hypofractionation estimated by fitting a Cox proportional hazards regression model, including a treatment arm indicator variable and adjusting for the three stratification factors employed in the randomization.
Délai Up to 3 years
Critère de jugement secondaire
Incidence of urinary adverse events
Will be graded per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0). The proportion of patients experiencing grade 3 or higher urinary/bowel toxicity within two years of initiation of treatment will be compared between the two treatment groups using a chi-square test. The 95% confidence interval (CI) width for the true difference will be at most ± 8.9%.
Délai Up to year 2
Critère de jugement secondaire
Incidence of bowel adverse events
Will be graded per CTCAE v 5.0. The proportion of patients experiencing grade 3 or higher urinary/bowel toxicity within two years of initiation of treatment will be compared between the two treatment groups using a chi-square test. The 95% CI width for the true difference will be at most ± 8.9%.
Délai Up to year 2
Critère de jugement secondaire
Quality of life
As measured by the Functional Assessment of Cancer Therapy-Bladder instrument.
Délai At baseline, 4 weeks, 16 weeks, 13 months, 25 months, and 37 months
Critère de jugement secondaire
Event free survival
Kaplan-Meier curves will be generated and the groups compared using a stratified logrank test (stratified by the randomization stratification factors). In addition, a Cox regression model will be fit, including treatment arm and the stratification factors.
Délai From randomization to histologically proven presence of MIBC, radiographic evidence of nodal or metastatic disease, or death from any cause, up to 5 years
Critère de jugement secondaire
Metastasis-free survival
Kaplan-Meier curves will be generated and the groups compared using a stratified logrank test. A Cox regression model will also be fit, including treatment arm and the stratification factors.
Délai From randomization to radiographic evidence of metastatic disease or death due to any cause, up to 5 years
Critère de jugement secondaire
Overall survival
Kaplan-Meier curves will be generated and the groups compared using a stratified logrank test. A Cox regression model will also be fit, including treatment arm and the stratification factors.
Délai From randomization to death from any cause, up to 5 years
Critère de jugement secondaire
Incidence of adverse events (AE)
Will be graded using CTCAE v 5.0. AE rates between the two treatment groups will be compared using chi-square or Fisher exact tests.
Délai Up to year 2
Critère de jugement secondaire
Circulating tumor deoxyribonucleic acid (ctDNA)
The association between the ctDNA results and imaging scans will be examined by generating 2x2 tables (presence/absence of minimal residual disease vs. positive/negative scan) at each time point and assessing the concordance between the results. For subjects who are ctDNA-positive at baseline, the proportion that clear ctDNA at the conclusion of RT treatment will be estimated in each arm. A point estimate of these proportions and their associated 95% Wilson score confidence interval will be reported. Clearance rates between the two arms will be compared using a chi-square or Fisher's exact test as appropriate.
Délai At baseline, end of treatment (week 4), weeks 16, 28, 40, 56, and at disease progression or last follow-up visit
Autre critère de jugement
ctDNA
Will be analyzed as prognostic markers by fitting Cox regression models for BI-EFS.
Délai At baseline, 4, 16, 28, 40, and 56 weeks from start of chemotherapy
Autre critère de jugement
Tissue free minimal residual disease
Will be obtained at the time of progression to determine if it captures the presence of disease. Will be analyzed as prognostic markers by fitting Cox regression models for BI-EFS.
Délai At time of progression
Autre critère de jugement
Urine tumor deoxyribonucleic acid
Will be analyzed as prognostic markers by fitting Cox regression models for BI-EFS.
Délai At baseline, 4, 16, 28, 40, and 56 weeks from start of chemotherapy
Autre critère de jugement
Primary outcome treatment effect by sex
The corresponding 95% CIs will be provided.
Délai Up to 5 years
Autre critère de jugement
Primary outcome treatment effect by race
The corresponding 95% CIs will be provided.
Délai Up to 5 years
Autre critère de jugement
Primary outcome treatment effect by ethnicity
The corresponding 95% CIs will be provided.
Délai Up to 5 years

Dates

Dates
Date de début	7 octobre 2025 (réelle)
Achèvement principal	31 mai 2030 (estimée)
Achèvement	31 mai 2035 (estimée)
Première publication	31 juillet 2025 (réelle)
Dernière mise à jour	18 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

204 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
OSF Saint Anthony's Health Center	Alton	Illinois	En recrutement
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	En recrutement
University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	En recrutement
Langlade Hospital and Cancer Center	Antigo	Wisconsin	En recrutement
Emory Saint Joseph's Hospital	Atlanta	Georgia	En recrutement
Grady Health System	Atlanta	Georgia	En recrutement
Emory University Hospital Midtown	Atlanta	Georgia	En recrutement
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	En recrutement
UCHealth University of Colorado Hospital	Aurora	Colorado	En recrutement
UH Seidman Cancer Center at UH Avon Health Center	Avon	Ohio	En recrutement
Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	En recrutement
Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	En recrutement
Louisiana Hematology Oncology Associates LLC	Baton Rouge	Louisiana	En recrutement
Bronson Battle Creek	Battle Creek	Michigan	En recrutement
UHHS-Chagrin Highlands Medical Center	Beachwood	Ohio	En recrutement
Billings Clinic Cancer Center	Billings	Montana	En recrutement
OSF Saint Joseph Medical Center	Bloomington	Illinois	En recrutement
Illinois CancerCare-Bloomington	Bloomington	Illinois	En recrutement
Central Care Cancer Center - Bolivar	Bolivar	Missouri	En recrutement
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	En recrutement
Bozeman Health Deaconess Hospital	Bozeman	Montana	En recrutement
University of Michigan - Brighton Center for Specialty Care	Brighton	Michigan	En recrutement
Henry Ford Cancer Institute-Downriver	Brownstown	Michigan	En recrutement
Minnesota Oncology - Burnsville	Burnsville	Minnesota	En recrutement
Illinois CancerCare-Canton	Canton	Illinois	En recrutement
Mercy Cancer Center - Cape Girardeau	Cape Girardeau	Missouri	En recrutement
Saint Francis Medical Center	Cape Girardeau	Missouri	En recrutement
Memorial Hospital of Carbondale	Carbondale	Illinois	En recrutement
SIH Cancer Institute	Carterville	Illinois	En recrutement
Illinois CancerCare-Carthage	Carthage	Illinois	En recrutement
Centralia Oncology Clinic	Centralia	Illinois	En recrutement
Christiana Care Health System-Concord Health Center	Chadds Ford	Pennsylvania	En recrutement
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	En recrutement
Medical University of South Carolina	Charleston	South Carolina	En recrutement
Memorial Hospital of Laramie County	Cheyenne	Wyoming	En recrutement
Rush MD Anderson Cancer Center	Chicago	Illinois	En recrutement
Northwestern University	Chicago	Illinois	En recrutement
University of Illinois	Chicago	Illinois	En recrutement
Case Western Reserve University	Cleveland	Ohio	En recrutement
Henry Ford Macomb Hospital-Clinton Township	Clinton Township	Michigan	En recrutement
Mercy Cancer Center-West Lakes	Clive	Iowa	En recrutement
UI Health Care Mission Cancer and Blood - West Des Moines Clinic	Clive	Iowa	En recrutement
Kootenai Health - Coeur d'Alene	Coeur d'Alene	Idaho	En recrutement
MU Health - University Hospital/Ellis Fischel Cancer Center	Columbia	Missouri	En recrutement
Ohio State University Comprehensive Cancer Center	Columbus	Ohio	En recrutement
Memorial Sloan Kettering Commack	Commack	New York	En recrutement
MD Anderson in The Woodlands	Conroe	Texas	En recrutement
Mercy Hospital	Coon Rapids	Minnesota	En recrutement
UM Sylvester Comprehensive Cancer Center at Coral Gables	Coral Gables	Florida	En recrutement
Greater Regional Medical Center	Creston	Iowa	En recrutement

161 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/NCT07097142