TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
Information source: Shandong University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Sex Cord Stromal Tumor; Ovarian Neoplasms; Ovarian Cancer
Intervention: Paclitaxel (Drug); Carboplatin (Drug); Bleomycin (Drug); Etoposide (Drug); Cisplatin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Beihua Kong Official(s) and/or principal investigator(s): Beihua Kong, MD. PhD., Principal Investigator, Affiliation: Qilu Hospital
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.
Clinical Details
Official title: A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-free survival
Secondary outcome: Chemotherapy related adverse effects in two armsTumor response rate Overall survival
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 6 courses in the absence of disease progression or
unacceptable toxicity.
ARM 2: Patients receive bleomycin IV per week, 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age≤70 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;
- Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within
the past 8 weeks.
- May or may not have measurable residual disease.
- Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1. 5
times the upper limit of normal, transaminase≤ 1. 5 times the upper limit of normal,
BUN, Cr≤ normal
- Performance status: Karnofsky score≥60;
- Provide written informed consent.
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.
Locations and Contacts
Qilu Hospital of Shandong University, Jinan, Shandong, China
Additional Information
Starting date: April 2015
Last updated: April 29, 2015
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