Study on Active Surveillance and Chemotherapy for Treating Germ Cell Tumors in Children and Adults

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03067181

Provider View

This clinical trial is exploring how well active monitoring and different chemotherapy drugs work in treating children and adults with germ cell tumors, which are a type of cancer that can occur in various parts of the body.

Patient Parameters

Program Overview

This study is investigating whether active surveillance, which involves closely monitoring patients after their tumor is removed, can effectively track low-risk germ cell tumors for any signs of recurrence. For tumors that have spread, the study is comparing two chemotherapy drugs, carboplatin and cisplatin, to see which is more effective in treating these metastatic germ cell tumors.

Description

The main goals of this study are to see if monitoring patients after surgery can maintain high survival rates for those with low-risk germ cell tumors and to compare the effectiveness of two chemotherapy regimens for standard-risk tumors. The study also looks at the side effects of these treatments, particularly hearing loss, and aims to develop a new way for patients to report their hearing outcomes.

Patients with low-risk tumors will be observed after surgery to check for any recurrence. If the cancer returns, they may switch to a standard-risk treatment plan. Patients with standard-risk tumors will be randomly assigned to receive one of two chemotherapy combinations:

  • Arm I (CEb): Patients receive bleomycin, carboplatin, and etoposide over several days, repeated every 21 days for up to 4 cycles.
  • Arm II (PEb): Patients receive bleomycin, etoposide, and cisplatin over several days, repeated every 21 days for up to 4 cycles.

For another group of standard-risk patients:

  • Arm III (BEC): Patients receive bleomycin, etoposide, and carboplatin over several days, repeated every 21 days for up to 3 cycles.
  • Arm IV (BEP): Patients receive bleomycin, etoposide, and cisplatin over several days, repeated every 21 days for up to 3 cycles.

Throughout the study, patients will undergo various tests, including scans and blood tests, to monitor their response to treatment. After completing the study treatment, patients will have regular follow-up visits for up to 10 years to check their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • No age limit for low-risk patients with stage I germ cell tumors.
  • Standard risk 1: Patients must be under 11 years old.
  • Standard risk 2: Patients must be between 11 and 25 years old.
  • Newly diagnosed with stage I germ cell tumor for low-risk arms or metastatic germ cell tumor for standard-risk arms.
  • Must have a confirmed diagnosis of a germ cell tumor.
  • Must meet specific tumor marker levels and histology requirements.
  • Must have a performance status score indicating they are well enough to participate.
  • Must have adequate kidney and liver function, as well as sufficient blood cell counts.
  • Must be medically fit to receive chemotherapy if in the standard-risk group.
  • Must be able to speak and read English for participation in certain parts of the study.
  • Must be followed for cancer care at specific participating institutions.

Exclusion Criteria

  • Patients with certain types of germ cell tumors not included in the study.
  • Patients who have had prior systemic therapy or radiation for their current cancer diagnosis.
  • Patients with significant respiratory disease that would make bleomycin unsafe.
  • Pregnant or breastfeeding women.
  • Sexually active patients who are not using effective contraception during the study.

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