- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373620
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
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 Contact
- Name: Jae-Hoon Kim, Professor
- Phone Number: +82-2-2019-3436
- Email: jaehoonkim@yumc.yonsei.ac.kr
Study Contact Backup
- Name: Hyun Hoon Chung, Fellow
- Phone Number: +82-2-2072-2821
- Email: chhkmj1@snu.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-720
- Recruiting
- Young-Dong Severance Hospital
-
Contact:
- Jae-Hoon Kim, Professor
- Phone Number: +82-2-2019-3436
- Email: jaehoonkim@yumc.yonsei.ac.kr
-
Sub-Investigator:
- Jae Weon Kim, Professor
-
Sub-Investigator:
- Noh Hyun Park, Professor
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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.
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.
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
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
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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