Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Study Overview
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Brief Summary
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To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy. The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.

Official Title
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A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Conventional whole breast radiation schedule
* Radiation: Hypofractionated whole breast radiation schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease. Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue. Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease. Exclusion Criteria: Tumour greater than 5 cm in greatest diameter on pathological examination. The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins. Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer. Bilateral malignancy of the breast (synchronous or metachronous). More than one primary invasive tumour in the same breast. Previous surgery for breast cancer. Pathological status of axilla is unknown. Status for adjuvant systemic therapy not determined. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast. For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy. Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment. Currently pregnant or lactating. Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm). Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \fIin situ\fR of the cervix which have been effectively treated. Geographic inaccessibility for follow-up. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated whole breast radiation<br>Subjects treated with 4250 cGY in 16 fractions | Radiation: Hypofractionated whole breast radiation schedule<br> <br> |
| Active Comparator: Conventional whole breast radiation<br>Subjects treated with 5000 cGY in 25 fractions | Radiation: Conventional whole breast radiation schedule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local breast recurrence |  | Indefinitely | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | Indefinitely | 
| Cost effectiveness |  | Indefinitely | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Hypofractionated Radiotherapy, Lumpectomy