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This is a phase III randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm: A | Experimental | regional nodal irradiation including axillary and supraclavicular lymph node groups along with chest wall or whole breast irradiation |
|
| Arm: B | No Intervention | chest wall or whole breast only irradiation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Nodal Irradiation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences ) | axillary, internal mammary or supraclavicular recurrences | time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free survival | local recurrence, regional recurrence, distant recurrence, contralateral breast recurrence and second primary cancer | Time from randomization until local, regional or distant recurrence, assessed up to 10 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | 11796 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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death from any cause |
| from randomization till death from any cause, assessed up to 10 years |
| Local Failure | chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy | from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years |
| D017437 |
| Skin and Connective Tissue Diseases |