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
Investigating Chemotherapy Options for Germ Cell Tumors
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.
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
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Age: 49 years or below
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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.
This study investigates the effects of different chemotherapy drugs on patients with germ cell tumors, which are a type of cancer that can occur in the ovaries, testicles, or other areas. The purpose is to compare carboplatin and cisplatin to determine which is more effective for patients with standard risk tumors. Germ cell tumors can be classified into different risk levels based on factors like their stage and location.
Participants in the study may undergo active surveillance, which means doctors will closely monitor them after tumor removal, or receive chemotherapy treatments with drugs like bleomycin, carboplatin, etoposide, or cisplatin. These drugs work by killing cancer cells, stopping them from dividing, or preventing them from spreading.
- Who can participate: Participants can be children or adults up to 49 years old. They must have low or standard risk germ cell tumors, such as stage I ovarian immature teratoma or malignant germ cell tumors. Specific age criteria apply for standard risk categories.
- Study details: Participants may receive active surveillance or chemotherapy involving drugs like bleomycin, carboplatin, etoposide, or cisplatin. Some may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
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