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

This study is currently recruiting participants.

Verified by Korean Gynecologic Oncology Group, December 2005

Sponsored by:	Korean Gynecologic Oncology Group
Information provided by:	Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00373620

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.

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

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

Study ID Numbers:	KGOG2001
Study First Received:	September 6, 2006
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00373620
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korean Gynecologic Oncology Group:

endometrial cancer
high risk
weekly paclitaxel
Cuncurrent chemoradiation

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Paclitaxel
Genital Neoplasms, Female

Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009