A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00340184
First received: June 20, 2006
Last updated: October 17, 2010
Last verified: January 2006

June 20, 2006
October 17, 2010
August 2004
Not Provided
Two year disease free survival
Same as current
Complete list of historical versions of study NCT00340184 on ClinicalTrials.gov Archive Site
5 year overall survical, toxicity profile
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Cancer
Drug: paclitaxel, carboplatin
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
Not Provided
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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.
Female
20 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00340184
KGOG1001
Not Provided
Not Provided
Korean Gynecologic Oncology Group
Not Provided
Study Chair: Soon Beom Kang, Professor Korean Gynecologic Oncology Group
Korean Gynecologic Oncology Group
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP