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

Endometrial Cancer Clinical Trial

Official title:

A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00373620
• Other study ID #: KGOG2001
• Status: Recruiting
• Phase: Phase 2
• First received: September 6, 2006
• Last updated: September 6, 2006
• Start date: January 2006

Study information

• Verified date: December 2005
• Source: Korean Gynecologic Oncology Group
• Contact: Jae-Hoon Kim, Professor
• Phone: +82-2-2019-3436
• Email: jaehoonkim[@]yumc.yonsei.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
Korea, Republic of	Young-Dong Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Gynecologic Oncology Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two year progression free survival
Secondary	toxicity profile