Clinical Trial: TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Ovarian Malignant Sex Cord-Stromal Tum

Brief 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 ovarian malignant sex cord-stromal tumor patients after surgery.

Detailed Summary:

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 ovarian malignant sex cord-stromal 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 6 courses in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive bleomycin IV per week, 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
Sponsor: Beihua Kong

Current Primary Outcome: Progression-free survival [ Time Frame: Date of randomization, and death due to any cause, assessed up to 5 years ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Chemotherapy related adverse effects in two arms [ Time Frame: Up to 5 years ]
  • Tumor response rate [ Time Frame: Up to 5 years ]
    The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).
  • Overall survival [ Time Frame: Up to 5 years ]
    The relationship of treatment to overall survival will be assessed using the proportional hazards model.


Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: April 24, 2015
Date Started: April 2015
Date Completion: May 2020
Last Updated: February 14, 2016
Last Verified: February 2016