Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
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|ClinicalTrials.gov Identifier: NCT00002807|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2020
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Radiation: radiation therapy||Not Applicable|
- Compare the overall survival in patients with intermediate-risk endometrial cancer treated with pelvic radiotherapy vs observation after laparoscopically-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy.
- Compare the time to locoregional recurrence (i.e., in the vaginal mucosa or elsewhere in the central pelvic area or lateral pelvic walls) in patients treated with these regimens.
- Compare the duration of ultimate pelvic control and event-free survival in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare sexual health issues in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, tumor grade (1 vs 2 vs 3), surgical staging (yes vs no), and sexual health assessment (yes vs no).
Patients undergo laparoscopic-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. After surgery, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo observation alone.
- Arm II: Beginning within 12 weeks (preferably within 6-8 weeks) after surgery, patients undergo radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Protocol-defined brachytherapy is allowed.
Quality of life is assessed at baseline; at 16-18 weeks after surgery (arm I) or 5 and 9 weeks after initiating radiotherapy (arm II); and then at 6, 12, 18, 24, 36, 48, and 60 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium|
|Actual Study Start Date :||July 4, 1996|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 21, 2009|
|No Intervention: Observation|
Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Radiation: radiation therapy
45 Gy in 25 fractions over 5 weeks
- Survival (combined with the ASTEC trial) [ Time Frame: 2009 ]
- Progression-free survival [ Time Frame: 2009 ]
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): NCT00002807
|Study Chair:||Himu R. Lukka, MD||Margaret and Charles Juravinski Cancer Centre|
|Study Chair:||Timothy J. Whelan, MD||Margaret and Charles Juravinski Cancer Centre|