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RECRUITING
NCT02429687
PHASE3

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

Sponsor: Beihua Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

14 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2015-04

Completion Date

2030-05

Last Updated

2023-04-25

Healthy Volunteers

No

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.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China