TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

NCT02429687RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Beihua Kong

Enrollment

129

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 Malignant Ovarian Germ Cell Tumors

Interventions

PaclitaxelCarboplatinBleomycinEtoposideCisplatin

Conditions

Ovarian Germ Cell CancerOvarian 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