Back to resultsA Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
Primary Purpose
Endometrial Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring endometrial cancer, high risk, weekly paclitaxel, Cuncurrent chemoradiation
Eligibility Criteria
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.
Sites / Locations
- Young-Dong Severance HospitalRecruiting
Outcomes
Primary Outcome Measures
Two year progression free survival
Secondary Outcome Measures
toxicity profile
Full Information
NCT ID
NCT00373620
First Posted
September 6, 2006
Last Updated
September 6, 2006
Sponsor
Korean Gynecologic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00373620
Brief Title
A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
Official Title
A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Korean Gynecologic Oncology Group
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer, high risk, weekly paclitaxel, Cuncurrent chemoradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Two year progression free survival
Secondary Outcome Measure Information:
Title
toxicity profile
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Hoon Kim, Professor
Phone
+82-2-2019-3436
Email
jaehoonkim@yumc.yonsei.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Hoon Chung, Fellow
Phone
+82-2-2072-2821
Email
chhkmj1@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Hoon Kim, Professor
Organizational Affiliation
Yong-Dong Severance Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Young-Dong Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Hoon Kim, Professor
Phone
+82-2-2019-3436
Email
jaehoonkim@yumc.yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae Weon Kim, Professor
First Name & Middle Initial & Last Name & Degree
Noh Hyun Park, Professor
First Name & Middle Initial & Last Name & Degree
Soon Beom Kang, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
25015202
Citation
Cho H, Nam BH, Kim SM, Cho CH, Kim BG, Ryu HS, Kang SB, Kim JH. A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study. Int J Radiat Oncol Biol Phys. 2014 Sep 1;90(1):140-6. doi: 10.1016/j.ijrobp.2014.05.024. Epub 2014 Jul 8.
Results Reference
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A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
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