Brief Title
A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
Official Title
A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.
Brief Summary
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.
Detailed 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Two year progression free survival
Secondary Outcome
toxicity profile
Condition
Endometrial Cancer
Intervention
paclitaxel
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
January 2006
Eligibility Criteria
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.
Gender
Female
Ages
20 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Jae-Hoon Kim, Professor, +82-2-2019-3436, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT00373620
Organization ID
KGOG2001
Study Sponsor
Korean Gynecologic Oncology Group
Study Sponsor
Jae-Hoon Kim, Professor, Study Chair, Yong-Dong Severance Hospital
Verification Date
December 2005