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Completed

NCT Number: NCT00340184

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paclitaxel, Carboplatin

Drug

Primary outcomes

  1. Two year disease free survival

Secondary outcomes

  1. 5 year overall survical, toxicity profile

Sponsors and collaborators

Lead sponsor

Korean Gynecologic Oncology Group

Other

Registry information

Official study title

A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy

Important dates

Study start
2004
First posted
Jun 21, 2006
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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