Clinical Trial: The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

Brief Summary: This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.

Detailed Summary:
Sponsor: Ding Ma

Current Primary Outcome: Disease-free survival (DFS) [ Time Frame: 3-year DFS ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Side effect of adjuvant chemotherapy [ Time Frame: 3-month，6-month，1-year and 3-year ]
  The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)
• Complications of radiotherapy [ Time Frame: 3-month，6-month，1-year and 3-year ]
  To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.
• Quality of Life [ Time Frame: 3-month，6-month，1-year and 3-year ]
• Overall survival (OS) [ Time Frame: 3-year OS ]

Original Secondary Outcome: Same as current

Information By: Huazhong University of Science and Technology

Dates:
Date Received: March 20, 2013
Date Started: November 2012
Date Completion:
Last Updated: March 26, 2013
Last Verified: March 2013