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Sponsored by: |
Korean Gynecologic Oncology Group |
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Information provided by: | Korean Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT00340184 |
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.
Condition | Intervention | Phase |
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Cervical Cancer |
Drug: paclitaxel, carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-Risk Cervical Cancer Patients After Radical Hysterectomy |
Estimated Enrollment: | 55 |
Study Start Date: | August 2004 |
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.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Study Chair: | Soon Beom Kang, Professor | Korean Gynecologic Oncology Group |
Study ID Numbers: | KGOG1001 |
Study First Received: | June 20, 2006 |
Last Updated: | June 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00340184 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
concurrent chemoradiation paclitaxel carboplatin |
Paclitaxel Tubulin Modulators Adjuvants, Immunologic |
Antimitotic Agents Carboplatin Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Carboplatin Antineoplastic Agents, Phytogenic Pharmacologic Actions |