Comparing two chemotherapy regimens for 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

This study is testing if a new combination of chemotherapy drugs can help people with newly diagnosed ovarian malignant sex cord-stromal tumors live longer and feel better compared to the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 14 Years to 65 Years
• Sex: Female
• Sponsor: Shandong University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT02429700 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of paclitaxel and carboplatin compared to the standard treatment of bleomycin, etoposide, and cisplatin in patients with newly diagnosed ovarian malignant sex cord-stromal tumors. The study will assess progression-free survival, overall survival, and toxicity levels associated with each treatment regimen. Participants will be randomly assigned to one of the two treatment arms and will undergo regular follow-ups for two years after treatment completion to monitor their health outcomes. Blood samples will also be collected for laboratory biomarker analysis throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese women aged 65 or younger with newly diagnosed, histologically confirmed ovarian stromal tumors who have undergone initial surgery within the past 8 weeks.

Not a fit: Patients with severe or uncontrolled internal diseases or those unsuitable for chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and less toxic treatment option for patients with ovarian malignant sex cord-stromal tumors.

How similar studies have performed: Other studies have shown success with similar chemotherapy regimens, but this specific comparison is novel.

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Beihua Kong, MD. PhD. — Qilu Hospital of Shandong University
• Study coordinator: Beihua Kong, MD. PhD.

Conditions Ovarian Sex Cord Stromal Tumor; Ovarian Neoplasms; Ovarian Cancer