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A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery


Phase 2
20 Years
75 Years
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

2 years after completion of study treatment

Safety Issue:

No

Principal Investigator

Joo-Hyun Nam, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Institutional Review Board

Study ID:

ANSGOG-001

NCT ID:

NCT01461746

Start Date:

October 2011

Completion Date:

September 2015

Related Keywords:

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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