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A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer


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

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Trial Information

A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

3 months after completion of study treatment

Safety Issue:

No

Authority:

Korea: Institutional Review Board

Study ID:

ANSGOG-002

NCT ID:

NCT01461759

Start Date:

October 2011

Completion Date:

September 2015

Related Keywords:

  • Advanced or Recurrent Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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