NCT00340184

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
Last Updated

October 19, 2010

Status Verified

January 1, 2006

First QC Date

June 20, 2006

Last Update Submit

October 17, 2010

Conditions

Cervical Cancer

Keywords

concurrentchemoradiationpaclitaxelcarboplatin

Outcome Measures

Primary Outcomes (1)

  • Two year disease free survival

Secondary Outcomes (1)

  • 5 year overall survical, toxicity profile

Interventions

paclitaxel, carboplatinDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Lee TS, Kang SB, Kim YT, Park BJ, Kim YM, Lee JM, Kim SM, Kim YT, Kim JH, Kim KT. Chemoradiation with paclitaxel and carboplatin in high-risk cervical cancer patients after radical hysterectomy: a Korean Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):304-10. doi: 10.1016/j.ijrobp.2013.01.035.

    PMID: 23642625DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Soon Beom Kang, Professor

    Korean Gynecologic Oncology Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 21, 2006

Study Start

August 1, 2004

Last Updated

October 19, 2010

Record last verified: 2006-01

Locations

KR(1)