TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors (SCST-01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Neoplasms; Ovarian Cancer; Ovarian Sex Cord Stromal Tumor
• Intervention / Treatment: Drug: Paclitaxel; Drug: Carboplatin; Drug: Bleomycin; Drug: Etoposide; Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Beihua Kong, MD. PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT (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.	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.; Other Names: Anzatax; TAX; 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.
Active Comparator: BEP (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.	Drug: Bleomycin; Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.; Other Names: BLM; BLEO; Blanoxan; Drug: Etoposide; Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.; Other Names: Etopophos; ETOP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Date of randomization, and death due to any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemotherapy related adverse effects in two arms		Up to 5 years
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).	Up to 5 years
Overall survival	The relationship of treatment to overall survival will be assessed using the proportional hazards model.	Up to 5 years

Collaborators and Investigators

• Sponsor: Beihua Kong
• Collaborators: Sun Yat-sen University; Huazhong University of Science and Technology; Zhejiang University
• Investigators: Principal Investigator: Beihua Kong, MD. PhD., Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2030

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Neoplasms, Gonadal Tissue; Ovarian Neoplasms; Sex Cord-Gonadal Stromal Tumors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Carboplatin; Etoposide; Paclitaxel; Bleomycin
• Other Study ID Numbers: SCST-01