TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors

NCT02429700RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Beihua Kong

Enrollment

132

Start Date

2015-04-01

Completion Date

2025-05-01

Study Type

INTERVENTIONAL

Official Title

A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tumors

Interventions

PaclitaxelCarboplatinBleomycinEtoposideCisplatin

Conditions

Ovarian Sex Cord Stromal TumorOvarian NeoplasmsOvarian Cancer

Eligibility

Age Range

14 Years – 65 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Progression-free survival

PFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.

Time frame: Date of randomization, and death due to any cause, assessed up to 5 years

Secondary Outcomes

Chemotherapy related adverse effects in two arms

Time frame: Up to 5 years

Tumor response rate

The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).

Time frame: Up to 5 years

Overall survival

The relationship of treatment to overall survival will be assessed using the proportional hazards model.

Time frame: Up to 5 years

Locations

Qilu Hospital of Shandong University, Jinan, China

TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors