Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340184
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2006-06-20
Brief Title:
A Safety and Efficacy of CCRT With PaclitaxelCarboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
Sponsor:
Korean Gynecologic Oncology Group
Organization:
Korean Gynecologic Oncology Group
Study Overview
Official Title:
A Phase II Trial of Radiation Therapy With Concurrent PaclitaxelCarboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxelcarboplatin 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 paclitaxelplatinum 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 paclitaxelcarboplatin in patients with postoperative high risk factors
Based on this obseration we evaluated the efficacy and safety of CCRT with paclitaxelcarboplatin in patients with postoperative high risk factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None