A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-operative Cervical Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00340184|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : October 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: paclitaxel, carboplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy|
|Study Start Date :||August 2004|
- Two year disease free survival
- 5 year overall survical, toxicity profile
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340184
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Study Chair:||Soon Beom Kang, Professor||Korean Gynecologic Oncology Group|