Clinical trial · Interventional
TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors
NCT02429700CI-TRIAL-00065938SCST-01recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Sex Cord Stromal Tumor | Ovarian Sex Cord-Stromal Tumor | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PT (Arm 1)
- description
- 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.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- BEP (Arm 2)
- description
- 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.
- interventionNames
- Drug: Bleomycin
- Drug: Etoposide
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.