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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Korean Gynecologic Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00373620
First received: September 6, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: paclitaxel
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 Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.

Resource links provided by NLM:


Further study details as provided by Korean Gynecologic Oncology Group:

Primary Outcome Measures:
  • Two year progression free survival

Secondary Outcome Measures:
  • toxicity profile

Estimated Enrollment: 50
Study Start Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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: NCT00373620

Contacts
Contact: Jae-Hoon Kim, Professor +82-2-2019-3436 jaehoonkim@yumc.yonsei.ac.kr
Contact: Hyun Hoon Chung, Fellow +82-2-2072-2821 chhkmj1@snu.ac.kr

Locations
Korea, Republic of
Young-Dong Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Jae-Hoon Kim, Professor    +82-2-2019-3436    jaehoonkim@yumc.yonsei.ac.kr   
Sub-Investigator: Jae Weon Kim, Professor         
Sub-Investigator: Noh Hyun Park, Professor         
Principal Investigator: Soon Beom Kang, Professor         
Sponsors and Collaborators
Korean Gynecologic Oncology Group
Investigators
Study Chair: Jae-Hoon Kim, Professor Yong-Dong Severance Hospital
  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: NCT00373620     History of Changes
Other Study ID Numbers: KGOG2001
Study First Received: September 6, 2006
Last Updated: September 6, 2006
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Gynecologic Oncology Group:
endometrial cancer
high risk
weekly paclitaxel
Cuncurrent chemoradiation

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
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 October 22, 2014