Clinical trial NCT02429687: TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Germ Cell Cancer
Ovarian Neoplasms
Ovarian Cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
name: Zhejiang University
name: Sun Yat-sen University
First posted: 2015-04-29
Enrollment: 129
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 malignant ovarian germ cell tumor patients after surgery.

Detailed description: PRIMARY OBJECTIVES:

To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin \[BEP\] as a reference) for newly diagnosed malignant ovarian germ cell tumors.

SECONDARY OBJECTIVES:

1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\* courses in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

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.

Primary outcomes:
measure: Progression-free survival
timeFrame: Date of randomization, and death due to any cause, assessed up to 5 years
Secondary outcomes:
measure: Chemotherapy related adverse effects in two arms
timeFrame: Up to 5 years
measure: Tumor response rate
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Beihua Kong
role: PRINCIPAL_INVESTIGATOR
References: