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

NCT02429687 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

DRUG

Bleomycin

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

DRUG

Etoposide

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

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.

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Beihua Kong

    lead OTHER

Principal Investigators

  • Beihua Kong · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2025-05-31
Completion
2030-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429687 on ClinicalTrials.gov