A Safety and Efficacy of CCRT With Paclitaxel/Carboplatin as Adjuvant Therapy to Post-Operative Cervical Cancer Patients - Full Text View

Sponsored by:	Korean Gynecologic Oncology Group
Information provided by:	Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00340184

Purpose

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
Cervical Cancer	Drug: paclitaxel, carboplatin	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

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

Further study details as provided by Korean Gynecologic Oncology Group:

Primary Outcome Measures:

Two year disease free survival

Secondary Outcome Measures:

5 year overall survical, toxicity profile

Estimated Enrollment:	55
Study Start Date:	August 2004

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, 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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Female

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340184

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Korean Gynecologic Oncology Group

Investigators

Study Chair:

Soon Beom Kang, Professor

Korean Gynecologic Oncology Group

More Information

Study ID Numbers:	KGOG1001
Study First Received:	June 20, 2006
Last Updated:	June 20, 2006
ClinicalTrials.gov Identifier:	NCT00340184
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korean Gynecologic Oncology Group:

concurrent
chemoradiation
paclitaxel
carboplatin

Study placed in the following topic categories:

Paclitaxel
Carboplatin

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009