Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after surgery.
PRIMARY OBJECTIVES: To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin \[BEP\] as a reference) for newly diagnosed malignant ovarian germ cell tumors. SECONDARY OBJECTIVES: 1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population. 2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. 3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\* courses in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses. Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGProgression-free survival
PFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
Time frame: Date of randomization, and death due to any cause, assessed up to 5 years
Chemotherapy related adverse effects in two arms
Time frame: Up to 5 years
Tumor response rate
The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).
Time frame: Up to 5 years
Overall survival
The relationship of treatment to overall survival will be assessed using the proportional hazards model.
Time frame: Up to 5 years
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Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.