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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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ClinicalTrials.gov Identifier: NCT00373620
Recruitment Status : Unknown
Verified December 2005 by Korean Gynecologic Oncology Group.
Recruitment status was:  Recruiting
First Posted : September 8, 2006
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:
Korean Gynecologic Oncology Group

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: paclitaxel Phase 2

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  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel




Primary Outcome Measures :
  1. Two year progression free survival

Secondary Outcome Measures :
  1. toxicity profile


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00373620     History of Changes
Other Study ID Numbers: KGOG2001
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: December 2005

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action