Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003749
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
1999-04
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 Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known whether conventional surgery is more effective with or without lymphadenectomy andor radiation therapy in treating endometrial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy andor radiation therapy in treating patients who have endometrial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy andor radiation therapy in treating patients who have endometrial cancer
Detailed Description:
OBJECTIVES
Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus
Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery
OUTLINE This is a randomized multicenter study Patients are randomized in both the surgery and radiotherapy segments of the study
Surgery Patients are randomized to 1 of 2 surgery arms
Arm I Patients undergo conventional surgery total abdominal hysterectomy and bilateral salpingo-oophorectomy
Arm II Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes
Radiotherapy Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms Patients may enter the radiotherapy randomization after surgery off study
Arm I Patients receive in 20-25 fractions of external beam radiotherapy total dose of 40-46 Gy over 4-5 weeks
Arm II Patients receive no external beam radiotherapy NOTE Some patients receive vault brachytherapy regardless of radiotherapy randomization
Quality of life is assessed before therapy and at 2 and 5 years after therapy
Patients are followed every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A minimum of 1400 patients will be accrued for the surgical component of this study and at least 900 patients including additional patients not participating in the surgical component of this study will be accrued for the radiotherapy component of this study
Compare the effects of conventional surgery alone and conventional surgery plus lymphadenectomy in patients with endometrial cancer preoperatively thought to be confined to the uterine corpus
Determine the effect of postoperative adjuvant external beam radiotherapy on quality of life and survival of a subset of these patients at high risk of relapse and with no macroscopic disease after surgery
OUTLINE This is a randomized multicenter study Patients are randomized in both the surgery and radiotherapy segments of the study
Surgery Patients are randomized to 1 of 2 surgery arms
Arm I Patients undergo conventional surgery total abdominal hysterectomy and bilateral salpingo-oophorectomy
Arm II Patients undergo conventional surgery as in arm I followed by lymphadenectomy with systematic dissection of the iliac and obturator nodes
Radiotherapy Patients at high risk of relapse who have no postoperative macroscopic disease are randomized to 1 of 2 radiotherapy arms Patients may enter the radiotherapy randomization after surgery off study
Arm I Patients receive in 20-25 fractions of external beam radiotherapy total dose of 40-46 Gy over 4-5 weeks
Arm II Patients receive no external beam radiotherapy NOTE Some patients receive vault brachytherapy regardless of radiotherapy randomization
Quality of life is assessed before therapy and at 2 and 5 years after therapy
Patients are followed every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A minimum of 1400 patients will be accrued for the surgical component of this study and at least 900 patients including additional patients not participating in the surgical component of this study will be accrued for the radiotherapy component of this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98062 | None | None | None |
| MRC-ASTEC | None | None | None |