NCT03067181ClinicalTrials.gov

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 31.780 Teilnehmende gesucht629 Studienzentren9 Länder

Kategorien

Onkologie100%

In 1 Register registriert

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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 2017-03-01; recorded start 2017-05-25
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 183 other studies in this databaseCounted from the lead sponsor named in the record (Children's Oncology Group)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 30 conditions.
Lead sponsor type recorded as: research network.
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 rigourMODERATE

A moderately rigorous 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 arm0/15
No comparator arm stated in the record
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: 629 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

ScaleLARGE

A large study, international in scope: 1,780 participants (target), run at 629 sites, across 9 countries.

How this score is built

Enrolment32/40
1,780 participants (target)
Site count25/25
629 sites
Country count12/15
9 countries
Planned duration10/10
Planned over about 123 months
Sponsor scale9/10
Children's Oncology Group has led 182 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.

Zusammenfassung

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

PRIMARY OBJECTIVES: I. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients with stage I (low risk) malignant germ cell tumors (Stratum 2), and at least 88% for patients with all stage/grade ovarian pure immature teratoma (Stratum 1). II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk non-seminomatous germ cell tumors. IIa. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin \[C\] etoposide \[E\] bleomycin \[b\]) vs. a cisplatin-based regimen (cisplatin \[P\]Eb) in children (less than 11 years in age) with standard risk germ cell tumors (GCT). IIb. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - \< 25 years) with standard risk GCT. SECONDARY OBJECTIVES: I. To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. II. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors. III. To determine whether radiomic measures of body composition at diagnosis, end of therapy, and one year after end of therapy is better correlated with adverse events compared to body surface area in patients receiving chemotherapy for germ cell tumors. EXPLORATORY OBJECTIVES: I. To prospectively determine the correlation of tumor marker decline (alpha-fetoprotein \[FP\] and beta-human chorionic gonadotropin \[HCG\]) with clinical outcome in low and standard risk germ cell tumor patients. II. To compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. III. Assess the relationship between hearing loss as measured by audiometry with the effects of tinnitus as assessed on the Adolescent and Young Adult Hearing Screening (AYA-HEARS) instrument. IV. To evaluate the prognostic significance of serum micro ribonucleic acid (miRNA)s in stage I seminoma patients by collecting clinical data and serum specimens for future analysis. V. To compare differences in the proportion of patients with residual mass(es) ≥ 1 cm at the completion of chemotherapy among patients randomized to the cisplatin and carboplatin-containing arms and to compare the proportion undergoing post-chemotherapy surgery for residual mass(es), and the proportion of resected masses with viable malignancy, teratoma, or necrosis. VI. To investigate whether there is an association between serum miRNAs measured immediately post-operatively and time-to-relapse in stage I non-seminomatous germ cell tumor patients and to estimate the trajectory of miRNA over time. OUTLINE: Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma malignant germ cell tumors (MGCT)s undergo observation and can transfer to standard risk arm at time of recurrence if eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or chest x-ray as well as blood sample collection throughout the trial to monitor for response and recurrence. Patients may also undergo a tumor biopsy throughout the trial. Patients with standard risk 1 are randomized into 1 of 2 arms. ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. Patients with standard risk 2 are randomized into 1 of 2 arms. ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM IV (BEP): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. After completion of study treatment, patients are followed up every 2 months for 12 months, every 3-6 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.

Erkrankungen

Childhood Extracranial Germ Cell Tumor
Extragonadal Embryonal Carcinoma
Germ Cell Tumor
Malignant Germ Cell Tumor
Malignant Ovarian Teratoma
Stage I Ovarian Choriocarcinoma
Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7
Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7
Stage I Testicular Choriocarcinoma AJCC v6 and v7
Stage I Testicular Embryonal Carcinoma AJCC v6 and v7
Stage I Testicular Seminoma AJCC v6 and v7
Stage I Testicular Yolk Sac Tumor AJCC v6 and v7
Stage II Ovarian Choriocarcinoma
Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7
Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7
Stage II Testicular Choriocarcinoma AJCC v6 and v7
Stage II Testicular Embryonal Carcinoma AJCC v6 and v7
Stage II Testicular Yolk Sac Tumor AJCC v6 and v7
Stage III Ovarian Choriocarcinoma
Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7
Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7
Stage III Testicular Choriocarcinoma AJCC v6 and v7
Stage III Testicular Embryonal Carcinoma AJCC v6 and v7
Stage III Testicular Yolk Sac Tumor AJCC v6 and v7
Stage IV Ovarian Choriocarcinoma
Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7
Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7
Testicular Mixed Choriocarcinoma and Embryonal Carcinoma
Testicular Mixed Choriocarcinoma and Teratoma
Testicular Mixed Choriocarcinoma and Yolk Sac Tumor

Eignung

Eignung
Geschlecht	Alle
Alter	Im Registereintrag nicht angegeben
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: * There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\]) * Standard risk 1: Patients must be \< 11 years of age at enrollment * Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment * Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher). * Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions: * Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided * Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \[AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently * Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \[\< 3 mm\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\< 1,000 ng/mL, beta-HCG institutional normal; all ages * Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages * Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages * Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \[IGCCC\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \< 11 * Standard risk 2 (SR2) * Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25 * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \< 1,000 ng/mL, beta-HCG \< 5,000 IU/mL and lactate dehydrogenase (LDH) \< 3.0 x normal; age (years) \>= 11 and \< 25 * Notes: * IGCCC criteria only apply to SR2 patients with a testicular primary tumor * Use post-op tumor marker levels to determine IGCCC risk group * Pure seminoma patients are not eligible for the standard risk arms of the study * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients) * Adequate renal function defined as: * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR * A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL) * 1 month to \< 6 months male: 0.4 female: 0.4 * 6 months to \< 1 year male: 0.5 female: 0.5 * 1 to \< 2 years male: 0.6 female: 0.6 * 2 to \< 6 years male: 0.8 female: 0.8 * 6 to \< 10 years male: 1 female: 1 * 10 to \< 13 years male: 1.2 female: 1.2 * 13 to \< 16 years: male: 1.5 female: 1.4 * \>= 16 years male: 1.7 female: 1.4 * Total bilirubin =\< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (within 7 days prior to enrollment) * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome * Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3 (within 7 days prior to enrollment) AND * Platelet count \>= 75,000/mm\^3 (within 7 days prior to enrollment) * Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment * Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \[PROs\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate * \>= 11 and \< 25 years old at enrollment * Able to fluently speak and read English * Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor * Followed for cancer or survivorship care at one of the following institutions: * Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center * Dana Farber/Harvard Cancer Center * Hospital for Sick Children * Children's Hospital of Eastern Ontario * Oregon Health and Science University * Seattle Children's Hospital * Yale University Exclusion Criteria: * Patients with any diagnoses not listed including: * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection) * Pure ovarian or extragonadal dysgerminoma/seminoma * Pure mature teratoma * Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL * "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or * Primary central nervous system (CNS) germ cell tumor * Germ cell tumor with somatic malignant transformation * Spermatocytic seminoma * Patients must have had no prior systemic therapy for the current cancer diagnosis * Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \[stage IV disease\] would be considered poor risk and therefore not eligible for this trial) * Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) * Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	1.780 Teilnehmende gesucht

Sponsor und Mitwirkende

Children's Oncology Group Sponsor
National Cancer Institute (NCI) Mitwirkende

Studienarme und Interventionen

Arm I (bleomycin, carboplatin, etoposide)EXPERIMENTAL
Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Arm II (bleomycin, etoposide, cisplatin)EXPERIMENTAL
Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Arm III (bleomycin, etoposide, carboplatin)EXPERIMENTAL
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Arm IV (bleomycin, etoposide, cisplatin)EXPERIMENTAL
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Low-Risk (observation)EXPERIMENTAL
Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.

Interventionen

Sonstige Best Practice
Undergo observation
Eingriff Biopsy Procedure
Undergo a tumor biopsy
Eingriff Biospecimen Collection
Undergo blood sample collection
Biologikum Bleomycin Sulfate
Given IV
Arzneimittel Carboplatin
Given IV
Arzneimittel Cisplatin
Given IV
Eingriff Computed Tomography
Undergo a CT scan
Arzneimittel Etoposide
Given IV
Eingriff Magnetic Resonance Imaging
Undergo MRI
Eingriff Pulmonary Function Test
Undergo a pulmonary function test
Sonstige Questionnaire Administration
Ancillary studies

Endpunkte

Primärer Endpunkt
Overall survival
The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first.
Zeitrahmen Two years post enrollment
Primärer Endpunkt
Event-free survival
The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first.
Zeitrahmen Two years post enrollment
Sekundärer Endpunkt
Presence of hearing loss
The hearing loss is evaluated according to the International Society of Pediatric Oncology criteria.
Zeitrahmen 8 weeks after the last dose of platin therapy
Sekundärer Endpunkt
Adolescents and Young Adults-Hearing Screen (AYA HEARs)
AYA HEARs is a 9-item questionnaire with each question scored on a 5-point Likert scale (range = 0-4).
Zeitrahmen Baseline, end of therapy, 2 months post-end of therapy, and 1 year after enrollment
Sekundärer Endpunkt
Whole body lean body mass
Imaging and radiology reports will be analyzed using Slice-O-Matic software (Tomovision), and imaging results will be used to calculate whole-body lean body mass.
Zeitrahmen At diagnosis, at end of therapy, and up to 1 year after end of therapy
Sonstiger Endpunkt
Event-free survival (EFS) for participants with and without tumor marker decline
Tumor marker decline is coded as yes versus no. The hazard ratio for participants with and without tumor marker decline will be presented. Patients who receive chemotherapy will be analyzed separately than patients in the low risk stratum.
Zeitrahmen Up to 2 years
Sonstiger Endpunkt
Self-reported peripheral neuropathy score
Self-reported peripheral neuropathy will be assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale.
Zeitrahmen Up to 12 months after end of therapy
Sonstiger Endpunkt
Presence of residual tumor
A patient will be considered to have residual tumor if the patient has a residual mass ≥ 1 cm at the completion of chemotherapy based on imaging reports.
Zeitrahmen Up to 12 months
Sonstiger Endpunkt
Serum mir-371a-3p levels
miR-371a-3p will be measured from frozen serum to estimate the association with time-to-relapse as well as sensitivity, specificity, negative predictive value, and positive predictive value.
Zeitrahmen Within six weeks of surgery, at relapse (cases) or the time closest to the case's relapse (controls), and the timepoint immediately preceding the "relapse" timepoint, up to 2 years

Daten

Daten
Startdatum	25. Mai 2017 (tatsächlich)
Primärer Abschluss	30. Juni 2027 (geschätzt)
Abschluss	30. Juni 2027 (geschätzt)
Erstveröffentlichung	1. März 2017 (tatsächlich)
Zuletzt aktualisiert	25. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	April 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

438 Studienzentren rekrutieren

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Monash Medical Center-Clayton Campus	Clayton	Victoria	Rekrutiert
John Hunter Children's Hospital	Hunter Regional Mail Centre	New South Wales	Rekrutiert
Royal Children's Hospital	Parkville	Victoria	Rekrutiert
Perth Children's Hospital	Perth	Western Australia	Rekrutiert
Princess Margaret Hospital for Children	Perth	Western Australia	Aktiv, rekrutiert nicht
Sydney Children's Hospital	Randwick	New South Wales	Rekrutiert
Queensland Children's Hospital	South Brisbane	Queensland	Rekrutiert
The Children's Hospital at Westmead	Westmead	New South Wales	Rekrutiert

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Alberta Children's Hospital	Calgary	Alberta	Rekrutiert
University of Alberta Hospital	Edmonton	Alberta	Rekrutiert
IWK Health Centre	Halifax	Nova Scotia	Rekrutiert
McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	Rekrutiert
Kingston Health Sciences Centre	Kingston	Ontario	Rekrutiert
Children's Hospital	London	Ontario	Rekrutiert
Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec	Rekrutiert
The Montreal Children's Hospital of the MUHC	Montreal	Quebec	Rekrutiert
Children's Hospital of Eastern Ontario	Ottawa	Ontario	Rekrutiert
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)	Québec		Rekrutiert
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	Rekrutiert
Janeway Child Health Centre	St. John's	Newfoundland and Labrador	Rekrutiert
Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario	Rekrutiert
Hospital for Sick Children	Toronto	Ontario	Rekrutiert
University Health Network-Princess Margaret Hospital	Toronto	Ontario	Rekrutiert
British Columbia Children's Hospital	Vancouver	British Columbia	Rekrutiert
CancerCare Manitoba	Winnipeg	Manitoba	Rekrutiert

India

India
Einrichtung	Stadt	Bundesland oder Region	Status
Tata Memorial Hospital	Mumbai		Rekrutiert

Japan

Japan
Einrichtung	Stadt	Bundesland oder Region	Status
Chiba University	Chiba-sgi	Chiba	Rekrutiert
Saitama Children's Medical Center	Chuo-ku	Saitama	Rekrutiert
Kyushu Univeristy	Higashiku	Fukuoka	Rekrutiert
Hiroshima University Hospital	Hiroshima		Rekrutiert
Hyogo Prefectural Kobe Children's Hospital	Kobe	Hyōgo	Rekrutiert
Kyoto Perfectural University of Medicine	Kyoto		Rekrutiert
Niigata Cancer Centre	Niigata	Chuo-ku	Rekrutiert
Hyogo College of Medicine	Nishinomiya, Hyogo		Ausgesetzt
Osaka City General Hospital	Osaka		Rekrutiert
Saitama Medical University International Medical Center	Saitama		Rekrutiert
Hokkaido University Hospital	Sapporo	Hokkaido	Rekrutiert
Tohoku University School of Medicine	Sendai	Aoba-ku	Rekrutiert
Keio University	Shinjuku-ku	Tokyo	Rekrutiert
National Cancer Center Hospital	Tokyo		Rekrutiert
Kokuritsu Seiiku Medical Research Center Hospital	Tokyo		Rekrutiert
University of Tsukuba Hospital	Tsukuba	Ibaraki	Rekrutiert
Kanagawa Children's Medical Center	Yokohama	Kanagawa	Rekrutiert

New Zealand

New Zealand
Einrichtung	Stadt	Bundesland oder Region	Status
Christchurch Hospital	Christchurch		Rekrutiert
Starship Children's Hospital	Grafton	Auckland	Rekrutiert

Puerto Rico

Puerto Rico
Einrichtung	Stadt	Bundesland oder Region	Status
HIMA San Pablo Oncologic Hospital	Caguas		Aktiv, rekrutiert nicht
San Jorge Children's Hospital	San Juan		Aktiv, rekrutiert nicht

Saudi Arabia

Saudi Arabia
Einrichtung	Stadt	Bundesland oder Region	Status
King Faisal Specialist Hospital and Research Centre	Riyadh		Ausgesetzt

United Kingdom

United Kingdom
Einrichtung	Stadt	Bundesland oder Region	Status
Sheffield Children's Hospital	Broomhall	England	Rekrutiert
Addenbrookes Hospital-Medical School	Cambridge	England	Rekrutiert

579 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT03067181