NCT02429700RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 25 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 24 Apr 2015
- Start date
- 1 Apr 2015
- Primary completion date
- 31 May 2025
- Lead sponsor
- Beihua Kong
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT02429700
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 132
- From 1 Apr 2015 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Concurrently participating in other clinical trials
- Unable or unwilling to sign informed consents;
- Unable or unwilling to abide by protocol.
Who the study is looking for
- 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.
Age in the registry: 14 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.