Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
|Childhood Embryonal Tumor Childhood Extracranial Germ Cell Tumor Childhood Extragonadal Germ Cell Tumor Childhood Malignant Ovarian Germ Cell Tumor Childhood Malignant Testicular Germ Cell Tumor Childhood Teratoma Ovarian Embryonal Carcinoma Ovarian Yolk Sac Tumor Stage II Malignant Testicular Germ Cell Tumor Stage IIA Ovarian Germ Cell Tumor Stage IIB Ovarian Germ Cell Tumor Stage IIC Ovarian Germ Cell Tumor Stage III Malignant Testicular Germ Cell Tumor Stage IIIA Ovarian Germ Cell Tumor Stage IIIB Ovarian Germ Cell Tumor Stage IIIC Ovarian Germ Cell Tumor Testicular Choriocarcinoma and Yolk Sac Tumor Testicular Embryonal Carcinoma||Procedure: conventional surgery Drug: cisplatin Drug: etoposide Biological: bleomycin sulfate Other: laboratory biomarker analysis||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors|
- 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.
- 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.
|Study Start Date:||November 2003|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes & etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 & 6).
After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (second-look) and/or 3 more courses of compressed consolidation chemotherapy.
After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.
Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, & 16.
Procedure: conventional surgery
Other Name: surgery, conventionalDrug: cisplatin
Other Names:Drug: etoposide
Other Names:Biological: bleomycin sulfate
Other Names:Other: laboratory biomarker analysis
No Intervention: Arm 2
Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.
Observation only for recurrence or development of an SMN
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00053352
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|Principal Investigator:||Anne Frazier, MD||Children's Oncology Group|