Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006027
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-07-05
Brief Title:
Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Study of Adjuvant Postoperative Irradiation With or Without CisplatinTaxol Chemotherapy Following TAHBSO for Patients With Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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 tissue Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer
Detailed Description:
OBJECTIVES
Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy
Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage IC-IIA vs IIB Patients are randomized to one of two treatment arms
Arm I Within 8 weeks after surgery patients receive radiotherapy once daily 5 days a week for 55 weeks
Arm II Within 8 weeks after surgery patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28 After completion of radiotherapy patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56 84 112 and 140
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 436 patients 218 per treatment arm will be accrued for this study
Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy
Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage IC-IIA vs IIB Patients are randomized to one of two treatment arms
Arm I Within 8 weeks after surgery patients receive radiotherapy once daily 5 days a week for 55 weeks
Arm II Within 8 weeks after surgery patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28 After completion of radiotherapy patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56 84 112 and 140
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 436 patients 218 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| GOG-0194 | None | None | None |
| CDR0000068040 | None | None | None |