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Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Ultra-hypofractionated | Experimental | 5 fractions of 5.7 Gy every other day in the breast or chest wall region, with or without the inclusion of regional lymph node drainage chains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant ultra-hypofractionated radiotherapy | Radiation | adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0 | Events of radiotherapy up to 3 months |
| Late toxicity | Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification. | Events after 3 months of radiotherapy completion |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional free survival | from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence | 3 years |
| Distant free survival | from the date of initiation of treatment until the date of progression of distant disease evidence |
| Measure | Description | Time Frame |
|---|---|---|
| Breast volume and toxicity relationship | We analyzed the impact of CTV (Clinical Target Volume) volume (representing breast size), and dosimetric data, with a special focus on the maximum dose and dose in homogeneity (defined as the absolute volumes of breast tissue exposed to ≥100%, ≥104% and ≥107% of the prescribed dose | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcel MF Fang, MD | Instituto de Pesquisa Prevent Senior | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Pesquisa Prevent Senior | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8433390 | Background | Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. | |
| 18355913 |
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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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Prospective phase 2 non-randomized single-arm study
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| 3 years |
| Overall survival | defined from the date of initiation of treatment until the patient's death | 3 years |
| Cosmesis change | was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up.
| week 10 and week 26 after the end of the treatment |
| QOL (Quality of Life) changes | was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOQ-C30 and EORTC QLQ-BR-23 scales. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | 3 years |
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| D017437 |
| Skin and Connective Tissue Diseases |