Ovarian Cancer Clinical Trial
— SCST-01Official 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
NCT number | NCT02429700 |
Other study ID # | SCST-01 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | May 2030 |
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.
Status | Recruiting |
Enrollment | 132 |
Est. completion date | May 2030 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 14 Years to 65 Years |
Eligibility | 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; - 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. |
Country | Name | City | State |
---|---|---|---|
China | Qilu Hospital of Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Beihua Kong | Huazhong University of Science and Technology, Sun Yat-sen University, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-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. | Date of randomization, and death due to any cause, assessed up to 5 years | |
Secondary | Chemotherapy related adverse effects in two arms | Up to 5 years | ||
Secondary | 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). | Up to 5 years | |
Secondary | Overall survival | The relationship of treatment to overall survival will be assessed using the proportional hazards model. | Up to 5 years |
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