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

Primary Purpose

Ovarian Sex Cord Stromal Tumor, Ovarian Neoplasms, Ovarian Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Bleomycin
Etoposide
Cisplatin
Sponsored by
Beihua Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Sex Cord Stromal Tumor

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PT (Arm 1)

BEP (Arm 2)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Chemotherapy related adverse effects in two arms
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).
Overall survival
The relationship of treatment to overall survival will be assessed using the proportional hazards model.

Full Information

First Posted
April 24, 2015
Last Updated
April 22, 2023
Sponsor
Beihua Kong
Collaborators
Huazhong University of Science and Technology, Zhejiang University, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02429700
Brief Title
TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
Acronym
SCST-01
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Beihua Kong
Collaborators
Huazhong University of Science and Technology, Zhejiang University, Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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: To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Sex Cord Stromal Tumor, Ovarian Neoplasms, Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PT (Arm 1)
Arm Type
Experimental
Arm Description
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 Title
BEP (Arm 2)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, TAX
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Other Intervention Name(s)
Blanoxan, BLEO, BLM
Intervention Description
Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
ETOP, Etopophos
Intervention Description
Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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 Measure Information:
Title
Progression-free survival
Description
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 Outcome Measure Information:
Title
Chemotherapy related adverse effects in two arms
Time Frame
Up to 5 years
Title
Tumor response rate
Description
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
Title
Overall survival
Description
The relationship of treatment to overall survival will be assessed using the proportional hazards model.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beihua Kong, MD. PhD.
Phone
+8618560081888
Email
kongbeihua@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beihua Kong, MD. PhD.
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beihua Kong, MD. PhD.

12. IPD Sharing Statement

Learn more about this trial

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

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