Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00053352|
Recruitment Status : Completed
First Posted : January 28, 2003
Results First Posted : December 8, 2017
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors|
|Actual Study Start Date :||November 3, 2003|
|Actual Primary Completion Date :||October 1, 2013|
|Actual Study Completion Date :||June 30, 2021|
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, conventional
Biological: bleomycin sulfate
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
- Event-Free Survival (EFS) [ Time Frame: 3 Years after enrollment ]Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.
- Overall Survival (OS) [ Time Frame: 3 Years after enrollment ]Percentage probability of being alive at 3 years following enrollment.
- Days Hospitalized for Patients Who Receive Chemotherapy [ Time Frame: Up to 126 days after the start of chemotherapy ]Calculated to quantify the treatment cost associated with this regimen.
- Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Up to 126 days after the start of chemotherapy ]The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053352
|Principal Investigator:||Anne Frazier, MD||Children's Oncology Group|