- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429687
TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors (MOGCT-01)
A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
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. |
Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
Other Names:
Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
Other Names:
Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 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.
|
Date of randomization, and death due to any cause, assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chemotherapy related adverse effects in two arms
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Tumor response rate
Time Frame: 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).
|
Up to 5 years
|
Overall survival
Time Frame: Up to 5 years
|
The relationship of treatment to overall survival will be assessed using the proportional hazards model.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Ovarian Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Carboplatin
- Etoposide
- Paclitaxel
- Bleomycin
Other Study ID Numbers
- MOGCT-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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