Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002807
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
1999-11-01
Brief Title:
Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064915 | OTHER | PDQ | None |
| CAN-NCIC-EN5 | OTHER | None | None |
| NCI-V96-0945 | OTHER_GRANT | None | None |