A Feasibility Study to Evaluate Intensity Modulated Radiation Therapy (IMRT) for Concomitant Boost Breast Radiotherapy (CBRT)
18 Years
N/A
Female
Breast Cancer
Trial Information
A Feasibility Study to Evaluate Intensity Modulated Radiation Therapy (IMRT) for Concomitant Boost Breast Radiotherapy (CBRT)
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, resulting in complex, conformal dose distributions. This technique offers
several advantages. A concomitant IMRT boost potentially offers improved dose distributions
by allowing more conformal doses around the boost volume and increased sparing of the
remaining breast and adjacent organs at risk. Several studies have shown better target dose
homogeneity resulting in less toxicity with adjuvant breast IMRT . One study found a
significant reduction in the rates of moist desquamation with IMRT compared to wedged
tangential fields (31% vs. 48%, P=0.0014).
Longer treatment duration increases the inconvenience and decreases patient compliance.
Furthermore, this places extra financial and emotional hardship on the patient and her
family, particularly if they must travel long distances between home and the treatment
centre. Studies have found 10-30% of patients do not receive adjuvant radiotherapy after
lumpectomy,placing these patients at higher risk for local recurrence and death from
disease. Radiobiologically, a boost increases the risk of late normal tissue effects. In the
EORTC study, they found significantly higher but limited rates of severe fibrosis at 10
years of 4.4% vs. 1.6% (p<0.0001) with the boost. No age effect was noted on the incidence
of fibrosis. One study compared a shorter hypofractionated schedule of 42.5 Gy/16 fractions
over 3.5 weeks with the standard schedule of 50 Gy/25 fractions over 5 weeks and observed
comparable 5 year local recurrence rates and cosmetic outcomes.
Inclusion Criteria:
1. 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.
2. Any of the following indications for boost radiotherapy to tumour bed:
1. Age ≤ 60 years
2. Positive or close resection margins (≤ 2 mm)
3. Lymphovascular space invasion
4. Extensive intraductal component (DCIS >25% of tumour volume)
3. Three or fewer axillary nodes involved as determined either by:
1. Sentinel node biopsy OR
2. Axillary node dissection OR
3. Clinical exam for patients with DCIS only or age greater than 70 years of age.
4. Informed consent.
Exclusion Criteria:
1. Age < 18 years.
2. Seroma or surgical cavity on CT estimated to be > 30% of the breast volume.
3. More than one primary tumour in different quadrants of the same breast.
4. Previous irradiation to the ipsilateral breast that would preclude whole breast
irradiation.
5. Presence of an ipsilateral breast implant or pacemaker.
6. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus
erythematosus (SLE), scleroderma) which would preclude definitive radiation
treatment.
7. For patients not treated with adjuvant chemotherapy: unable to commence radiation
therapy within 12 weeks of the last surgical procedure on the breast.
8. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of
the last dose of chemotherapy.
9. 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.
10. Currently pregnant or lactating.
11. Psychiatric or addictive disorders which would preclude obtaining informed consent or
adherence to protocol.
12. Geographic inaccessibility for follow-up.
13. Regional lymphatic irradiation planned.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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 without major treatment deviation.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Fei-Fei Liu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 07-0594-C
NCT ID:
NCT00981864
Start Date:
November 2008
Completion Date:
December 2011
Related Keywords:
- Breast Cancer
- radiation therapy in breast cancer
- concurrent radiation
- Breast cancer patients
- Breast Neoplasms
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