TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
SCST-01
A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
ExpectedApril 25, 2023
April 1, 2023
10.1 years
April 24, 2015
April 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Chemotherapy related adverse effects in two arms
Up to 5 years
Tumor response rate
Up to 5 years
Overall survival
Up to 5 years
Study Arms (2)
PT (Arm 1)
EXPERIMENTALPatients 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.
BEP (Arm 2)
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beihua Konglead
- Huazhong University of Science and Technologycollaborator
- Zhejiang Universitycollaborator
- Sun Yat-sen Universitycollaborator
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beihua Kong, MD. PhD.
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD. PhD.
Study Record Dates
First Submitted
April 24, 2015
First Posted
April 29, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2025
Study Completion (Estimated)
May 1, 2030
Last Updated
April 25, 2023
Record last verified: 2023-04