Clinical trial Recruiting at 438 sites Phase 3 Interventional

Monitoring and treating germ cell tumors in children and adults

Official title: 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

Run by Children's Oncology Group · NCT03067181 · Data updated 2026-11-12

This study is testing whether a combination of careful monitoring and chemotherapy can help children and adults with low-risk germ cell tumors stay healthy after surgery, while also comparing two different chemotherapy drugs and looking at their effects on hearing.

More Germ Cell Tumor trials

Quick facts

PhasePhase 3
Study typeInterventional
SexAll
Enrollment1780 (estimated)
SponsorChildren's Oncology Group
Research network
Drugs / interventionschemotherapy, radiation
Locations629 sites (Birmingham, Alabama and 628 other locations)
StatusRecruiting
StartedMay 25, 2017
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedAugust 25, 2026
Trial IDNCT03067181 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include pediatric, adolescent, and young adult patients newly diagnosed with low-risk or standard risk germ cell tumors.

Probably not a fit

Patients with high-risk germ cell tumors or those who have previously received treatment for germ cell tumors may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the effectiveness of active surveillance combined with chemotherapy in patients with low-risk germ cell tumors after surgical removal. It aims to maintain high overall survival rates for pediatric and adult patients with stage I malignant germ cell tumors while comparing the event-free survival of carboplatin versus cisplatin-based regimens in treating metastatic standard risk germ cell tumors. The study also investigates the incidence of ototoxicity associated with these chemotherapy regimens and seeks to validate a patient-reported measure of hearing outcomes.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with germ cell tumors, potentially reducing the need for aggressive chemotherapy.

How similar studies have gone: Other studies have shown promising results with similar approaches in managing germ cell tumors, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 \[SR1 and SR2 patients\])

Where it's running

  • Children's Hospital of Alabama
    Birmingham, Alabama, United States
    Recruiting
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Women's Cancer Care
    Anchorage, Alaska, United States
    Recruiting
  • Katmai Oncology Group
    Anchorage, Alaska, United States
    Recruiting
Show 44 more locations
  • Providence Alaska Medical Center
    Anchorage, Alaska, United States
    Recruiting
  • Kingman Regional Medical Center
    Kingman, Arizona, United States
    Recruiting
  • Banner Children's at Desert
    Mesa, Arizona, United States
    Recruiting
  • Phoenix Childrens Hospital
    Phoenix, Arizona, United States
    Recruiting
  • Arkansas Children's Hospital
    Little Rock, Arkansas, United States
    Recruiting
  • CARTI Cancer Center
    Little Rock, Arkansas, United States
    Recruiting
  • Kaiser Permanente-Anaheim
    Anaheim, California, United States
    Recruiting
  • PCR Oncology
    Arroyo Grande, California, United States
    Recruiting
  • Kaiser Permanente-Bellflower
    Bellflower, California, United States
    Recruiting
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California, United States
    Recruiting
  • Kaiser Permanente Downey Medical Center
    Downey, California, United States
    Recruiting
  • Kaiser Permanente-Fontana
    Fontana, California, United States
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • Loma Linda University Medical Center
    Loma Linda, California, United States
    Recruiting
  • Miller Children's and Women's Hospital Long Beach
    Long Beach, California, United States
    Recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, United States
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Recruiting
  • Mattel Children's Hospital UCLA
    Los Angeles, California, United States
    Recruiting
  • Valley Children's Hospital
    Madera, California, United States
    Recruiting
  • Providence Queen of The Valley
    Napa, California, United States
    Recruiting
  • UCSF Benioff Children's Hospital Oakland
    Oakland, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • Children's Hospital of Orange County
    Orange, California, United States
    Recruiting
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-San Diego Mission
    San Diego, California, United States
    Recruiting
  • Rady Children's Hospital - San Diego
    San Diego, California, United States
    Recruiting
  • Naval Medical Center -San Diego
    San Diego, California, United States
    Recruiting
  • UCSF Medical Center-Mission Bay
    San Francisco, California, United States
    Recruiting
  • Providence Medical Foundation - Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Providence Santa Rosa Memorial Hospital
    Santa Rosa, California, United States
    Recruiting
  • Children's Hospital Colorado
    Aurora, Colorado, United States
    Recruiting
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
    Denver, Colorado, United States
    Recruiting
  • Connecticut Children's Medical Center
    Hartford, Connecticut, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware, United States
    Recruiting
  • Children's National Medical Center
    Washington D.C., District of Columbia, United States
    Recruiting
  • Broward Health Medical Center
    Fort Lauderdale, Florida, United States
    Recruiting
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida, United States
    Recruiting
  • UF Health Cancer Institute - Gainesville
    Gainesville, Florida, United States
    Recruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida, United States
    Recruiting
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida, United States
    Recruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida, United States
    Recruiting

+579 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: A. L Frazier — Children's Oncology Group

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Teniposide plus cisplatin for newly diagnosed central malignant germ cell tumors

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    Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07188441

  • ZW251 for advanced liver, lung, and germ cell cancers

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  • Maintenance zanzalintinib with oral etoposide after high-dose chemotherapy for germ cell tumor

    This treatment tests whether daily zanzalintinib together with cycles of oral etoposide can help people with relapsed or refractory germ cell tumors after high-dose chemotherapy and stem-cell transplant.

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  • Low-dose aspirin to prevent venous blood clots during chemotherapy for advanced germ cell (testicular) cancer

    This trial will see if taking one daily low-dose aspirin (81 mg) during cisplatin chemotherapy prevents venous blood clots over six months in adults up to age 70 with high-risk advanced germ cell or testicular cancer.

    Recruiting at 3 sites Phase 2 Wake Forest University Health Sciences · Charlotte, North Carolina and 2 other locations · NCT06866964

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.