Actively Recruiting

Phase 3
Age: 14Years - 65Years
FEMALE
NCT02429700

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

Led by Beihua Kong · Updated on 2023-04-25

132

Participants Needed

1

Research Sites

787 weeks

Total Duration

On this page

Sponsors

B

Beihua Kong

Lead Sponsor

H

Huazhong University of Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female Chinese women aged 14 to 65 years
  • Histologically confirmed ovarian stromal tumor of specified cell types including granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor, steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, or sex cord tumor with annular tubules
  • Newly diagnosed stage IIA-IVB disease
  • Surgery for diagnosis, staging, or cytoreduction performed within the past 8 weeks
  • May or may not have measurable residual disease
  • Laboratory tests meeting specified minimum blood counts and liver and kidney function limits
  • Karnofsky performance score of 60 or higher
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Severe or uncontrolled internal disease preventing surgery or chemotherapy
  • History of organ transplantation or immune diseases
  • History of serious mental illness or brain dysfunction
  • History of drug abuse
  • Presence of other malignancies
  • Participation in other clinical trials
  • Unable or unwilling to sign informed consent
  • Unable or unwilling to comply with the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

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Research Team

B

Beihua Kong, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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