Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Study Overview
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Brief Summary
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Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.

Detailed Description
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Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).

Official Title
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Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Conditions
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Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost

Intervention / Treatment
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* Radiation: Hypofractionation with simultaneous integrated boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins Indication to adjuvant radiotherapy including boost radiotherapy Clearly identified primary tumor region preferably by radiopaque clips Primary wound healing after breast conserving therapy without signs of infection Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated Written informed consent Exclusion Criteria: Patients operated by mastectomy No indication for boost radiation Resection margins positive for disease or insufficient identification of the boost volume Indication for radiotherapy of the regional lymph nodes History of prior breast or thoracic radiotherapy Extended postoperative seroma at the beginning of radiotherapy Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionation with SIB<br> | Radiation: Hypofractionation with simultaneous integrated boost<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Skin Toxicity | Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients treated on Protocol | Dose constraints Dmedian lung < 10 Gy; Dmedian heart < 5 Gy, Dmax ≤ 40 Gy; Dmedian anterior branch of the left coronary artery (LAD, RIVA) < 15 Gy, Dmax ≤ 40 Gy; Dmedian contralateral breast < 3 Gy | 22-29 days (16 fractions) | 
| Acute General Toxicity | All dimensions of NCI-CTCAE | 0 to 6 months | 
| Quality of life Score | EORTC QLQ-C30, -BR23 | 0 to 6 months | 
| Performance | ECOG | 0 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Hypofractionation, Simultaneous integrated boost, Toxicity