Status:
COMPLETED
Concurrent Boost Radiotherapy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary aim of this study is to evaluate the feasibility of delivering 42.5 Gy to the breast with a concomitant 10 Gy boost to the tumour bed in 16 fractions for a total duration of 3.5 weeks usin...
Detailed Description
Rather than a sequential boost, we propose delivering a concomitant boost using intensity modulated radiotherapy (IMRT). IMRT is a sophisticated technique deliberately using multiple non-uniform beams...
Eligibility Criteria
Inclusion
- Female patient with a new histological diagnosis of invasive carcinoma OR ductal carcinoma-in-situ (DCIS) of the breast and no evidence of metastatic disease.
- Any of the following indications for boost radiotherapy to tumour bed:
- Age ≤ 60 years
- Positive or close resection margins (≤ 2 mm)
- Lymphovascular space invasion
- Extensive intraductal component (DCIS \>25% of tumour volume)
- Three or fewer axillary nodes involved as determined either by:
- Sentinel node biopsy OR
- Axillary node dissection OR
- Clinical exam for patients with DCIS only or age greater than 70 years of age.
- Informed consent.
Exclusion
- Age \< 18 years.
- Seroma or surgical cavity on CT estimated to be \> 30% of the breast volume.
- More than one primary tumour in different quadrants of the same breast.
- Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation.
- Presence of an ipsilateral breast implant or pacemaker.
- Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
- For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast.
- For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy.
- Previous or concomitant malignancies except for patients with nonmelanoma skin cancer, contralateral non-invasive breast cancer or carcinoma in situ of any other site. In addition, patients with invasive cancers treated more than 5 years previously and without evidence of recurrence will be eligible.
- Currently pregnant or lactating.
- Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
- Geographic inaccessibility for follow-up.
- Regional lymphatic irradiation planned.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00981864
Start Date
November 1 2008
End Date
December 1 2011
Last Update
December 21 2012
Active Locations (1)
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1
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9