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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
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Korean Gynecologic Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00340184     History of Changes
Other Study ID Numbers: KGOG1001
Study First Received: June 20, 2006
Last Updated: October 17, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Gynecologic Oncology Group:
concurrent
chemoradiation
paclitaxel
carboplatin

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014