Ovarian Sex Cord Stromal TumorPhase 3SCST-01NCT02429700
TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors
A Phase 3 study testing Paclitaxel, Carboplatin and Bleomycin in people with Ovarian Sex Cord Stromal Tumor and Ovarian Neoplasms, run by Beihua Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Ovarian Sex Cord Stromal Tumor, Ovarian Neoplasms, Ovarian Cancer
- What is being tested?
- Paclitaxel, Carboplatin and Bleomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Beihua Kong, MD. PhD.
About this study
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
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.
Read the 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.
- Being tested
- Paclitaxel, Carboplatin, Bleomycin, Etoposide, Cisplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Anzatax, TAX
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.
CarboplatinDrug
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.
BleomycinDrug
Also called Blanoxan, BLEO, BLM
Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
EtoposideDrug
Also called ETOP, Etopophos
Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
CisplatinDrug
Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| PT (Arm 1) | Experimental | 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. Receives: Drug: Paclitaxel; Drug: Carboplatin |
| BEP (Arm 2) | Active comparator | 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. Receives: Drug: Bleomycin; Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of randomization, and death due to any cause, assessed up to 5 years
Secondary outcomes (3)
Chemotherapy related adverse effects in two arms
Measured: 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).
Measured: Up to 5 years
Overall survival
The relationship of treatment to overall survival will be assessed using the proportional hazards model.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2025 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Sex Cord Stromal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beihua Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Zhejiang University, Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Beihua Kong, Shandong University
- Investigators
- Beihua Kong, MD. PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429700
- Sponsor's protocol ID
- SCST-01
- Acronym
- SCST-01
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2015
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes