RecruitingPhase 3NCT02429687

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

A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors


Sponsor

Beihua Kong

Enrollment

129 participants

Start Date

Apr 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 14 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy regimens — TC (paclitaxel and carboplatin) versus BEP (bleomycin, etoposide, and cisplatin) — in women with rare ovarian tumors called malignant germ cell tumors, to find out which approach is safer and more effective. **You may be eligible if...** - You are a Chinese woman aged 65 or younger - You have been diagnosed with a specific rare type of ovarian germ cell tumor, confirmed by biopsy - Your cancer was newly diagnosed at a moderately advanced to advanced stage - You had your initial surgery within the past 8 weeks - Your blood counts and organ function are within acceptable ranges - Your overall health is reasonably good **You may NOT be eligible if...** - You have severe or uncontrolled medical conditions that prevent surgery or chemotherapy - You have had an organ transplant or have immune system diseases - You have serious mental illness or significant brain dysfunction - You have a history of drug or substance abuse - You have another active cancer - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

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.

DRUGCarboplatin

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.

DRUGBleomycin

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

DRUGEtoposide

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

DRUGCisplatin

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

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NCT02429687


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