NCT02429700 TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
| NCT ID | NCT02429700 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beihua Kong |
| Condition | Ovarian Sex Cord Stromal Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2015-04 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 132 participants in total. It began in 2015-04 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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; * 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.
Contact & Investigator
Beihua Kong, MD. PhD.
PRINCIPAL INVESTIGATOR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT02429700 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 65 Years, studying Ovarian Sex Cord Stromal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02429700 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 132 participants.
Is NCT02429700 currently recruiting?
Yes, NCT02429700 is actively recruiting participants. Contact the research team at kongbeihua@sdu.edu.cn for enrollment information.
Where is the NCT02429700 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT02429700 clinical trial?
NCT02429700 is sponsored by Beihua Kong. The principal investigator is Beihua Kong, MD. PhD. at Qilu Hospital of Shandong University. The trial plans to enroll 132 participants.