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

September 6, 2006
September 6, 2006
January 2006
Not Provided
Two year progression free survival
Same as current
No Changes Posted
toxicity profile
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
Drug: paclitaxel
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
Not Provided

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.
Female
20 Years to 75 Years
No
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
Korea, Republic of
 
NCT00373620
KGOG2001
Not Provided
Not Provided
Korean Gynecologic Oncology Group
Not Provided
Study Chair: Jae-Hoon Kim, Professor Yong-Dong Severance Hospital
Korean Gynecologic Oncology Group
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP