AGCT1531: 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

Recruiting
49 years or below
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to compare the effects good and/or bad of carboplatin with cisplatin on people with standard risk germ cell tumors to find out which is better.

Detailed description of study

This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, 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.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: germ cell tumor,germ cell tumors,germ cell ,tumor,tumors,cancer,oncology,pediatric,riley,kid,kids,adolescent,youth
  • Age: 49 years or below
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Up to 49 Years (Child, Adult)
  • Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites])
  • Standard risk 1: Patient must be < 11 years of age at enrollment
  • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
  • Low risk stage I immature teratoma (IT); site: ovarian
  • Low risk stage I MCGT; site: ovarian, testicular, or extragonadal
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal
  • Standard risk 2 (SR2); site: Ovarian, testicular, extragonadonal

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 04 Aug 2024. Study ID: 1904451893 (1705463860) (PHO-COG-FALLON-AGCT1531)

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