TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors (MOGCT-01)

  • STATUS
    Recruiting
  • End date
    May 18, 2030
  • participants needed
    129
  • sponsor
    Beihua Kong
Updated on 13 February 2022
paclitaxel
etoposide
residual tumor
carboplatin
germ cell tumor
carboplatin/paclitaxel
cytoreduction

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.

Description

PRIMARY OBJECTIVES:

To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed malignant ovarian germ cell tumors.

SECONDARY OBJECTIVES:

  1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
  2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
  3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin 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.

ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4* courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Details
Condition Ovarian Germ Cell Cancer, Ovarian Neoplasms, Ovarian Cancer
Treatment cisplatin, etoposide, carboplatin, Paclitaxel, Bleomycin
Clinical Study IdentifierNCT02429687
SponsorBeihua Kong
Last Modified on13 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age65 years; female, Chinese women
Histologically confirmed ovarian stromal tumor, including the following cell types
Granulosa cell tumor
Granulosa cell-theca cell tumor
Sertoli-Leydig cell tumor (androblastoma)
Steroid (lipid) cell tumor
Gynandroblastoma
Unclassified sex cord-stromal tumor
Sex cord tumor with annular tubules
Newly diagnosed, stage IIA-IVB disease
Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks
May or may not have measurable residual disease
Laboratory tests: WBC410(9)/L, NEU210(9)/L, PLT8010(9)/L, serum bilirubin 1.5 times the upper limit of normal, transaminase 1.5 times the upper limit of normal, BUN, Cr normal
Performance status: Karnofsky score60
Provide written informed consent

Exclusion Criteria

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
Suffering from other malignancies
Concurrently participating in other clinical trials
Unable or unwilling to sign informed consents
Unable or unwilling to abide by protocol
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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