Back to resultsA Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paclitaxel, carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring concurrent, chemoradiation, paclitaxel, carboplatin
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Seoul National University Hospital
Outcomes
Primary Outcome Measures
Two year disease free survival
Secondary Outcome Measures
5 year overall survical, toxicity profile
Full Information
NCT ID
NCT00340184
First Posted
June 20, 2006
Last Updated
October 17, 2010
Sponsor
Korean Gynecologic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00340184
Brief Title
A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
Official Title
A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Korean Gynecologic Oncology Group
4. Oversight
5. Study Description
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 identified to compromise the treatment outcome. They include lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion. In these patients, postoperative RT is commonly recommended and has been demonstrated to improve the local control, but not survival rate. Recently, It is reported that the additon of concurrent chemotherapy to postoperative RT reduced pelvic failures and enhanced progression free survival. In addition, paclitaxel/platinum combination chemotherapy was demonstrated to have superior progression-free survical over single agent platinum in a primary treatment of stage IV or recurrent cervical cancer.
Based on this obseration, we evaluated the efficacy and safety of CCRT with paclitaxel/carboplatin in patients with postoperative high risk factors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
concurrent, chemoradiation, paclitaxel, carboplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paclitaxel, carboplatin
Primary Outcome Measure Information:
Title
Two year disease free survival
Secondary Outcome Measure Information:
Title
5 year overall survical, toxicity profile
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon Beom Kang, Professor
Organizational Affiliation
Korean Gynecologic Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23642625
Citation
Lee TS, Kang SB, Kim YT, Park BJ, Kim YM, Lee JM, Kim SM, Kim YT, Kim JH, Kim KT. Chemoradiation with paclitaxel and carboplatin in high-risk cervical cancer patients after radical hysterectomy: a Korean Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):304-10. doi: 10.1016/j.ijrobp.2013.01.035.
Results Reference
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A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
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