A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors
Overview
- Phase
- Phase 3
- Intervention
- Paclitaxel
- Conditions
- Ovarian Sex Cord Stromal Tumor
- Sponsor
- Beihua Kong
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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 ovarian malignant sex cord-stromal tumor patients after surgery.
Detailed Description
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 ovarian malignant sex cord-stromal 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.
Investigators
Beihua Kong
MD. PhD.
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Age≤65 years; female, Chinese women;
- •Histologically confirmed ovarian stromal tumor, including the following cell types:
- •Granulosa cell tumor
- •Granulosa cell-theca cell tumor
- •Sertoli-Leydig cell tumor (androblastoma)
- •Steroid (lipid) cell tumor
- •Gynandroblastoma
- •Unclassified sex cord-stromal tumor
- •Sex cord tumor with annular tubules
- •Newly diagnosed, stage IIA-IVB disease;
Exclusion Criteria
- •With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy;
- •History of organ transplantation, immune diseases;
- •History of serious mental illness, a history of brain dysfunction;
- •Drug abuse or a history of drug abuse;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
Arms & Interventions
PT (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.
Intervention: Paclitaxel
PT (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.
Intervention: Carboplatin
BEP (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.
Intervention: Bleomycin
BEP (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.
Intervention: Etoposide
BEP (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.
Intervention: Cisplatin
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Date of randomization, and death due to any cause, assessed up to 5 years
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.
Secondary Outcomes
- Tumor response rate(Up to 5 years)
- Overall survival(Up to 5 years)
- Chemotherapy related adverse effects in two arms(Up to 5 years)