Clinical Trial: Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

Brief Summary: This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.

Detailed Summary:

OBJECTIVES:

I. Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin (low-risk disease closed to accrual as of 01/20/10).

II. Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated.

III. Determine the percentage of intermediate-risk patients who require only 3 courses of therapy.

IV. Determine the acute toxic effects of compressed therapy in these patients. V. Determine the long-term sequelae in patients treated with this regimen. VI. Determine the number of hospital days and total drug doses required for patients treated with compressed therapy.

VII. Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study.

VIII. Determine the cytogenetic and molecular genetic features in patients treated with this regimen.

OUTLINE: Patients are stratified according to disease risk (low vs intermediate).

SURGERY: Patients undergo surgical resection.

Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression. Patients who remain disease free receive no further treatment. Pat
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Event-free survival (EFS) of at least 92% (for intermediate-risk tumors only) defined as the first occurrence of relapse, progressive disease, second malignancy, or death after the start of protocol-specified chemotherapy [ Time Frame: Assessed up to 3 years ]
    A piecewise exponential failure rate model for the theoretical EFS time for both the low and intermediate risk patients will be used.
  • Overall survival (OS) of at least 95% (both low-risk and intermediate-risk tumors) [ Time Frame: Assessed up to 4 years ]
    The model for OS will also be derived from a piecewise exponential failure rate model. The distribution of the complementary log-log transformation of the Kaplan-Meier estimate of the four-year survival will be used to calculate a 95% confidence interval for the true death rate.


Original Primary Outcome:

Current Secondary Outcome:

  • Days of hospitalization [ Time Frame: During treatment ]
    Calculated to quantify the treatment cost associated with this regimen.
  • Toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: During and after completion of study treatment ]
    The descriptions and grading scales found in the revised National Cancer Institute CTCAE v 4 will be used.


Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: January 27, 2003
Date Started: November 2003
Date Completion:
Last Updated: May 6, 2016
Last Verified: May 2016