Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002851
Status:
UNKNOWN
Last Update Posted:
2010-01-29
First Post:
1999-11-01
Brief Title:
Lymph Node Radiation Therapy in Patients With Stage I Stage II or Stage III Breast Cancer That Has Been Surgically Removed
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR IM-MS LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER
Status:
UNKNOWN
Status Verified Date:
2004-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 may kill any tumor cells remaining after surgery
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I stage II or stage III breast cancer that has been surgically removed
PURPOSE This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I stage II or stage III breast cancer that has been surgically removed
Detailed Description:
OBJECTIVES
Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival disease-free survival metastasis-free survival and cause of death in women with resected stage IIIIII breast cancer
OUTLINE This is a randomized multicenter study Patients are stratified by participating institution tumor location type of prior breast surgery pathologic T and N stage menopausal status and time sequence of radiotherapy and adjuvant chemotherapy Patients are randomized to 1 of 2 arms
Arm I Patients receive no nodal irradiation
Arm II Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day 5 sessions per week for a total of 25 fractions over 5 weeks Radiotherapy must begin no later than 8 weeks after surgery If adjuvant chemotherapy is given radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery
Patients are followed at least yearly after randomization for up to 20 years
PROJECTED ACCRUAL A total of 4000 patients will be accrued for this study within 4 years
Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival disease-free survival metastasis-free survival and cause of death in women with resected stage IIIIII breast cancer
OUTLINE This is a randomized multicenter study Patients are stratified by participating institution tumor location type of prior breast surgery pathologic T and N stage menopausal status and time sequence of radiotherapy and adjuvant chemotherapy Patients are randomized to 1 of 2 arms
Arm I Patients receive no nodal irradiation
Arm II Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day 5 sessions per week for a total of 25 fractions over 5 weeks Radiotherapy must begin no later than 8 weeks after surgery If adjuvant chemotherapy is given radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery
Patients are followed at least yearly after randomization for up to 20 years
PROJECTED ACCRUAL A total of 4000 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| EORTC-22922 | None | None | None |
| EORTC-10925 | None | None | None |