A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients

September 6, 2006 updated by: Korean Gynecologic Oncology Group

A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.

The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
        • Recruiting
        • Young-Dong Severance Hospital
        • Contact:
        • Sub-Investigator:
          • Jae Weon Kim, Professor
        • Sub-Investigator:
          • Noh Hyun Park, Professor
        • Principal Investigator:
          • Soon Beom Kang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection
  • Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV.
  • 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 history of arrhythmia,congestive heart failure.
  • Patients with intractable infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Two year progression free survival

Secondary Outcome Measures

Outcome Measure
toxicity profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Gynecologic Oncology Group

Investigators

  • Study Chair: Jae-Hoon Kim, Professor, Yong-Dong Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 6, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 8, 2006

Last Update Submitted That Met QC Criteria

September 6, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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