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TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors
Sponsor: Beihua Kong
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
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.
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.
Bleomycin
Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
Etoposide
Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
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