Health TrialsbyHealthPanel

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

ConditionsOvarian Germ Cell CancerOvarian NeoplasmsOvarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age14-65
SponsorBeihua Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age≤65 years; female, Chinese women;

Granulosa cell tumor

Granulosa cell-theca cell tumor

Sertoli-Leydig cell tumor (androblastoma)

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paclitaxel

    Drug

    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

    Drug

    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

    Drug

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

  • Etoposide

    Drug

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

  • Cisplatin

    Drug

    Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment groups

129 Participants
are divided into 2 treatment groups
Group A: PT (Arm 1)Experimental treatment 2 interventions
Group B: BEP (Arm 2)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

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.

Time frame
Date of randomization, and death due to any cause, assessed up to 5 years

Secondary outcomes

1

Chemotherapy related adverse effects in two arms

Time frame
Up to 5 years
2

Tumor response rate

The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).

Time frame
Up to 5 years
3

Overall survival

The relationship of treatment to overall survival will be assessed using the proportional hazards model.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beihua Kong

Lead sponsor

Shandong University

Sponsor institution

Huazhong University of Science and Technology

Collaborator

Zhejiang University

Collaborator

Sun Yat-sen University

Collaborator

Source ClinicalTrials.gov
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