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

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 Tumors

Overview

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 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 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 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.

Interventions

• Drug 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.
• Drug 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.
• Drug Bleomycin
  Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
• Drug Etoposide
  Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
• Drug 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.

Primary outcome measures

• Progression-free survival [Time frame: Date of randomization, and death due to any cause, assessed up to 5 years]

Secondary outcome measures (3)

• Chemotherapy related adverse effects in two arms [Time frame: Up to 5 years]
• Tumor response rate [Time frame: Up to 5 years]
• Overall survival [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

• Age≤65 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: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(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 score≥60;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT02429700 · SCST-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗