Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002546
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
1999-11-01
Brief Title:
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy AHWAR Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I II III or IV Carcinosarcoma CS of The Uterus
Status:
COMPLETED
Status Verified Date:
2016-02
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus
Detailed Description:
OBJECTIVES
Compare the survival progression-free interval and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin
Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks followed by radiotherapy boost to the pelvis 5 days a week for 22 weeks
Arm II Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4 Treatment continues every 3 weeks for 3 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 216 patients will be accrued for this study within 6 years
Compare the survival progression-free interval and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin
Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks followed by radiotherapy boost to the pelvis 5 days a week for 22 weeks
Arm II Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4 Treatment continues every 3 weeks for 3 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 216 patients will be accrued for this study within 6 years
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 |
|---|---|---|---|
| CDR0000063303 | OTHER | None | None |
| ECOG-G150 | None | None | None |
| NCI-2012-02226 | OTHER | NCI | None |