Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002459
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected Stage I or II High-Grade Uterine Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-09
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 tumor cells It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed
Detailed Description:
OBJECTIVES I Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected stage I or II high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone
OUTLINE This is a randomized multicenter study Patients are stratified according to center tumor histology leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma and surgical procedure total abdominal hysterectomy TAH with or without bilateral salpingo-oophorectomy BSO vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies Patients are randomized to 1 of 2 treatment arms Arm I Beginning within 6 weeks after surgery patients undergo pelvic radiotherapy 5 days a week for 56 weeks Arm II Patients undergo observation alone Patients are followed every 2 months for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study within 3 years
OUTLINE This is a randomized multicenter study Patients are stratified according to center tumor histology leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma and surgical procedure total abdominal hysterectomy TAH with or without bilateral salpingo-oophorectomy BSO vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies Patients are randomized to 1 of 2 treatment arms Arm I Beginning within 6 weeks after surgery patients undergo pelvic radiotherapy 5 days a week for 56 weeks Arm II Patients undergo observation alone Patients are followed every 2 months for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 200 patients 100 per arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-EN4 | None | None | None |
| EORTC-55874 | None | None | None |