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The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy, in relation to the time of treatment interruption and acute effects. This study evaluates whether there is an increase in treatment time with the addition of the bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous tissue. The patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.
Rational:
Description:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Risk - No bolus | Other | No Bolus |
|
| Standard Risk - Alternate Bolus | Other | Alternate 5mm Bolus |
|
| High Risk - Alternate Bolus | Other | Alternate 5mm Bolus |
|
| High Risk - Continuous bolus | Other | Continuous 5mm bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Bolus | Radiation | no bolus use |
| |
| Alternate Bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Acute radiodermatitis | Radiation Therapy Oncology Group (RTOG) grading system Common Terminology Criteria for Adverse Events (CTCAE) - v4.0 | participants will be followed for the duration of radiotherapy, an expected average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interruption Time | Treatment Interruption time due to radiodermatitis | participants will be followed for the duration of radiotherapy, an expected average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Local Care Costs | Local Care Costs with radiodermatitis | participants will be followed for the duration of radiotherapy, an expected average of 6 weeks |
| Local Control | local control in the chest wall assessed by physical examination and complementary exams. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas G Sapienza, MD, PhD | AC Camargo Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AC Camargo Cancer Center | São Paulo | São Paulo | 01509-010 | Brazil |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Radiation |
0.5cm bolus use in alternate days |
|
| Continuous Bolus | Radiation | 0.5 cm bolus use in continuous days |
|
| From date of randomization until the date of first documented local progression in the chest wall or date of death from any cause, whichever came first, assessed up to 100 months |
| Metastasis-Free Interval | Metastasis-Free Interval (following departmental post-treatment surveillance visits routine). | From date of randomization until the date of first documented distant progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall Survival | Overall Survival (following departmental post-treatment surveillance visits routine). | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |