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A Randomised Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumours

Status
Active
Cancer Type
Germ Cell Tumor
Ovarian Cancer
Trial Phase
Phase III
Eligibility
11 - 45 Years, Male and Female
Study Type
Treatment
NCD ID
NCT02582697
Protocol IDs
AGCT1532 (primary)
AGCT1532
NCI-2017-00559
Study Sponsor
Childrens Oncology Group

Summary

This randomized phase III trial studies how well an accelerated schedule of bleomycin sulfate, etoposide phosphate, and cisplatin (BEP) chemotherapy works compared to the standard schedule of BEP chemotherapy in treating patients with intermediate or poor-risk germ cell tumors that have spread to other places in the body. Drugs used in chemotherapy, such as bleomycin sulfate, etoposide phosphate, 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. Giving BEP chemotherapy on a faster, or “accelerated” schedule may work better with fewer side effects in treating patients with intermediate or poor-risk metastatic germ cell tumors.

Objectives

PRIMARY OBJECTIVES:
I. To compare the two treatment arms with respect to progression-free survival (disease progression or death).

SECONDARY OBJECTIVES:
I. To compare the two treatment arms with respect to response following treatment completion (protocol-specific response criteria).
II. To compare the two treatment arms with respect to adverse events (worst grade according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03).
III. To compare the two treatment arms with respect to health-related quality of life (summary scales from Quality of Life Questionnaire [QLQ]-C30 & -Testicular Cancer [TC]-26).
IV. To compare the two treatment arms with respect to treatment preference (proportion preferring each treatment arm).
V. To compare the two treatment arms with respect to delivered dose-intensity of chemotherapy (relative to standard BEP).
VI. To compare the two treatment arms with respect to overall survival (death from any cause).

TERTIARY OBJECTIVES:
I. Determine associations between biomarkers to be specified and their correlations with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive bleomycin sulfate intravenously (IV) over 60 minutes on days 1, 8, and 15 or 2, 9, and 16, etoposide phosphate IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Courses repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving fewer than 8 doses of bleomycin sulfate due to pulmonary toxicity receive ifosfamide IV, etoposide phosphate IV, and cisplatin IV on days 1-5. Courses repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bleomycin sulfate IV over 60 minutes on days 1 and 8 or 2 and 9, etoposide phosphate IV on days 1-5, and cisplatin IV on days 1-5. Courses repeat every 14 days for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving fewer than 8 doses of bleomycin sulfate due to pulmonary toxicity receive ifosfamide IV, etoposide phosphate IV, and cisplatin IV on days 1-5. Courses repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks, patients then receive bleomycin sulfate IV over 60 minutes weekly for 4 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months, monthly until disease progression, and then every 6 months after disease progression.
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