Comparing two treatment regimens for malignant ovarian germ cell tumors

A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors

This study is testing if a new combination of drugs can help people with malignant ovarian germ cell tumors do better after surgery compared to the usual treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 14 Years to 65 Years
• Sex: Female
• Sponsor: Shandong University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT02429687 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 malignant ovarian germ cell tumors following surgery. The study will assess progression-free survival, overall survival, and toxicity levels associated with each treatment regimen. Patients will be randomized into two groups, receiving either the new treatment or the standard regimen, with follow-up assessments conducted over several years to monitor outcomes. Blood samples will also be collected for laboratory biomarker analysis throughout the study.

Who should consider this trial

Good fit: Ideal candidates are Chinese women aged 65 or younger with newly diagnosed, histologically confirmed malignant ovarian germ cell tumors who have undergone initial surgery.

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 malignant ovarian germ cell tumors.

How similar studies have performed: Other studies have shown success with similar treatment comparisons, indicating potential for meaningful advancements in this area.

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

Conditions Ovarian Germ Cell Cancer; Ovarian Neoplasms; Ovarian Cancer