Status:

UNKNOWN

Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer

Lead Sponsor:

Asan Medical Center

Collaborating Sponsors:

Boryung Pharmaceutical Co., Ltd

Conditions:

Endometrial Cancer

Eligibility:

FEMALE

20-75 years

Phase:

PHASE2

Brief Summary

Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cis...

Eligibility Criteria

Inclusion

  • One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of \[Grade III, LVSI+, Mm\>1/2\] Clear cell or serous carcinoma: stage IB-II
  • Age: 20-75
  • ECOG PS: 0-2
  • Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine \<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
  • Informed Consent

Exclusion

  • Previous chemotherapy or pelvic RT
  • Hormone therapy within 4 weeks
  • Other malignant disease
  • Uncontrolled medical disease
  • Infection requiring antibiotics
  • Symptomatic CHF, RF, Angina, Arrhythmia, etc.
  • Neurosis or psychosis
  • Etc.

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2017

Estimated Enrollment :

67 Patients enrolled

Trial Details

Trial ID

NCT01461746

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