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A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.


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

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Trial Information

A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.


Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial
cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to
improve survival. Paclitaxel (P) has shown in vitro and clinical activity against
endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in
G2/M phase. This study is to evaluate the efficacy and safety of a treatment with
concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial
cancer.


Inclusion Criteria:



- Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing
cytology, pelvic and paraaortic lymph node dissection

- Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III,
IV.

- Patients must have a GOG performance of 0, 1, or 2.

- Patients must have expected life span over 6 months.

Exclusion Criteria:

- Patients with peripheral neurotoxicity over grade 2 in CTC criteria.

- Patients with history of chemotherapy or radiation treatment.

- patients with history of arrhythmia,congestive heart failure.

- Patients with intractable infection.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Two year progression free survival

Principal Investigator

Jae-Hoon Kim, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Yong-Dong Severance Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

KGOG2001

NCT ID:

NCT00373620

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial cancer
  • high risk
  • weekly paclitaxel
  • Cuncurrent chemoradiation
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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