MOGCT-01: TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

Sponsor

Beihua Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT02429687

Collaborator

Huazhong University of Science and Technology (Other), Zhejiang University (Other), Sun Yat-sen University (Other)

129

Enrollment

Location

Arms

181

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Germ Cell Cancer Ovarian Neoplasms Ovarian Cancer	Drug: Paclitaxel Drug: Carboplatin Drug: Bleomycin Drug: Etoposide Drug: Cisplatin	Phase 3

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:

To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PT (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.	Drug: Paclitaxel Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Other Names: Anzatax TAX Drug: Carboplatin and carboplatin AUC 5-6 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.
Active Comparator: BEP (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.	Drug: Bleomycin Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles. Other Names: Blanoxan BLEO BLM Drug: Etoposide Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles. Other Names: ETOP Etopophos Drug: Cisplatin Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.

Arm

Intervention/Treatment

Experimental: PT (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.

Drug: Paclitaxel

Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

Other Names:

Anzatax

TAX

Drug: Carboplatin

and carboplatin AUC 5-6 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.

Active Comparator: BEP (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.

Drug: Bleomycin

Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.

Other Names:

Blanoxan

BLEO

BLM

Drug: Etoposide

Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.

Other Names:

ETOP

Etopophos

Drug: Cisplatin

Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.

Outcome Measures

Primary Outcome Measures

Progression-free survival [Date of randomization, and death due to any cause, assessed up to 5 years]
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.

Secondary Outcome Measures

Chemotherapy related adverse effects in two arms [Up to 5 years]
Tumor response rate [Up to 5 years]
The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).
Overall survival [Up to 5 years]
The relationship of treatment to overall survival will be assessed using the proportional hazards model.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.