Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS

Study Overview
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Brief Summary
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A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

Detailed Description
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This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).

Official Title
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Randomized Prospective Study of Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following Breast Conservative Surgery

Conditions
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Radiotherapy Side Effect

Intervention / Treatment
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* Radiation: Sequential boost
* Radiation: Concomitant boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathologically proven breast cancer resected by lumpectomy Female patient Invasive breast cancer Negative surgical margin Age < or equal 50 years, or high-grade irrespective of age Appropriate stage for protocol entry i.e. no metastasis Performance Status 0-2 Hormone receptor status: ER/PR Known Borderline results are considered positive Exclusion Criteria: Metastatic patients Paget's disease of nipple Non-epithelial breast malignancy e.g. sarcoma, lymphoma Unresected suspicious microcalcifications in the same or contralateral breast Pregnant women Inability to delineate lumpectomy cavity Psychiatric or addictive disorders rendering treatment or follow-up difficult
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequential boost<br>Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus sequential boost 10 Gy/4 fx (2.5 Gy/fx) to lumpectomy cavity | Radiation: Sequential boost<br>* Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation<br>|
| Experimental: Concomitant boost<br>Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus concomitant boost 8 Gy/15 fx (0.53 Gy/fx) to lumpectomy cavity | Radiation: Concomitant boost<br>* Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Breast Cosmetic Outcome | Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction: Breast Questionnaire (Breast Q) | Using Breast Questionnaire (Breast Q) | 1 year | 
| Acute Toxicity (Breast Skin) | Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria | During treatment and up to 3 months after treatment | 
| Late Toxicity (Breast Skin, Heart, Lungs) | Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria | 1 year |