Status:

UNKNOWN

Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

Lead Sponsor:

Asan Medical Center

Collaborating Sponsors:

Boryung Pharmaceutical Co., Ltd

Conditions:

Advanced or Recurrent Endometrial Cancer

Eligibility:

FEMALE

20-75 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel ...

Eligibility Criteria

Inclusion

  • Histologically confirmed chemotherapy naïve endometrial cancer
  • One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
  • FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
  • At least one measurable lesion by RECIST on CT
  • ECOG PS: 0-2
  • Age: 20-75
  • Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine\<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
  • Informed Consent
  • Contraception during study period

Exclusion

  • Previous chemotherapy
  • RT, hormone therapy, or immunotherapy within 1 month
  • Other malignant disease
  • Uncontrolled medical disease
  • Infection requiring antibiotics
  • Symptomatic CHF, RF, Angina, Arrhythmia, etc.
  • Neurosis or psychosis
  • Pregnancy, breast-feeding
  • Etc.

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2017

Estimated Enrollment :

59 Patients enrolled

Trial Details

Trial ID

NCT01461759

Start Date

October 1 2011

End Date

December 1 2017

Last Update

May 31 2017

Active Locations (1)

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1

Asan Medical Center

Seoul, South Korea, 138-736