Status:
COMPLETED
A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
Lead Sponsor:
Korean Gynecologic Oncology Group
Conditions:
Cervical Cancer
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical cancer patients.
Detailed Description
Stage Ib to IIa cervical cancer can be treated effectively with either radioterapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors have been ident...
Eligibility Criteria
Inclusion
- Patients undertaken radical hysterectomy with diagnosis of invasive cervical cancer Ib-IIa (non-small cell type)
- Patients must have at least one of the following risk factors; pelvic lymph node involvemet, involvement of vaginal resection margin,parametrial invasion.
- Patients must have a GOG performance of 0, 1, or 2.
- Patients must have expected life span over 6 months.
Exclusion
- Patients with peripheral neurotoxicity over grade 2 in CTC criteria.
- Patients with history of chemotherapy or radiation treatment.
- Patients with histologicallly proven or highly suspected metastasis to paraaortic lymph node.
- Patients with history of hypersensitive reaction to platinum agent.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00340184
Start Date
August 1 2004
Last Update
October 19 2010
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744