A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients

Korean Gynecologic Oncology Group

Status and phase: Unknown; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00373620

KGOG2001

Details and patient eligibility

About

The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.

Full description

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.

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)