A Multi-centre Randomized Trial to Determine if Accelerated Partial Breast Irradiation, Utilizing 3D CRT, is as Effective as Whole Breast Irradiation Following Breast Conserving Surgery in Women With Ductal Carcinoma in Situ or Invasive Breast Cancer With Negative Axillary Lymph Nodes
40 Years
N/A
Female
Breast Cancer
Trial Information
A Multi-centre Randomized Trial to Determine if Accelerated Partial Breast Irradiation, Utilizing 3D CRT, is as Effective as Whole Breast Irradiation Following Breast Conserving Surgery in Women With Ductal Carcinoma in Situ or Invasive Breast Cancer With Negative Axillary Lymph Nodes
Following breast conserving surgery or on completion of chemotherapy, patients will be
stratified according to age, tumour histology, tumour size, adjuvant hormonal therapy and
clinical centre. Patients will be allocated to receive either whole breast irradiation or
3D CRT accelerated partial breast irradiation.
Radiation therapy will be administered as soon as possible following the healing of the
surgical incision (3-4 weeks) and within 12 weeks if the patient is not treated with
chemotherapy. If the patient is treated with chemotherapy, radiation therapy will begin
after 2 weeks and not beyond 8 weeks after the last dose of chemotherapy.
Patients treated with whole breast irradiation will receive a total dose of 42.5 Gy in 16
fractions, given on a daily basis, over a time period of 22 days. Patients with large
breast size are permitted to receive a total dose of 50 Gy in 25 fractions, given on a daily
basis, over a time period of 35 days. Boost irradiation is permitted in patients treated
with whole breast irradiation. Boost irradiation of 10 Gy/4-5 fractions daily over a time
period of 4-7 days is permitted for patients deemed at moderate to high risk of local
recurrence as per local cancer centre guidelines.
Patients treated with 3D CRT accelerated partial breast irradiation will receive a total
dose of 38.5 Gy in 10 fractions, delivered twice a day, over a time period of 5-8 days.
Each daily dose must be separated by 6-8 hours.
Patients will be followed indefinitely and assessed formally at 6 and 12 months after the
date of randomization and then on a yearly basis. Patients will be assessed for acute and
late radiation toxicity, cardiac toxicity, recurrent disease, new primary cancer, cosmetic
outcome, quality of life and overall survival.
Inclusion Criteria:
- 1a. Female patient with a new histological diagnosis of DCIS only. OR
1b. Female patient with a new histological diagnosis of invasive carcinoma of the
breast and no evidence of metastatic disease.
2. Treated by BCS with microscopically clear resection margins for invasive and
non-invasive disease (or no residual disease on re- excision).
3. Negative axillary node involvement including micrometastasis <= 0.2mm or
positive cells only identified by IHC as determined either by: (i) sentinel node
biopsy (ii) axillary node dissection or (iii) clinical exam for patients with DCIS
only
Exclusion Criteria:
- 1. Age < 40 years.
2. A known deleterious mutation in BRCA 1 and/or BRCA 2.
3. Tumour size > 3 cm in greatest diameter on pathological examination (including
both the invasive and non-invasive component).
4. Tumour histology limited to lobular carcinoma only.
5. History of cancer:
- Patients with another active malignancy or malignancy treated < 5 years prior to
randomization are excluded.
- Patients with a prior diagnosis of invasive or non-invasive breast cancer in
either breast are excluded regardless of disease free interval. Patients with
concurrent invasive or non-invasive contralateral breast cancer are also
excluded.
- Patients with prior or concurrent basal cell or squamous cell skin cancers are
eligible for the trial.
6. More than one primary tumour in different quadrants of the same breast.
7. Previous irradiation to the ipsilateral breast that would preclude whole
breast irradiation.
8. Presence of an ipsilateral breast implant or pacemaker.
9. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus
erythematosus (SLE), scleroderma) which would preclude definitive radiation
treatment.
10. Estrogen receptor status (ER) not known.
11. For patients not treated with adjuvant chemotherapy: unable to commence
radiation therapy within 12 weeks of the last surgical procedure on the breast.
12. For patients treated with adjuvant chemotherapy: unable to commence within
8 weeks of the last dose of chemotherapy.
13. Currently pregnant or lactating.
14. Psychiatric or addictive disorders which would preclude obtaining informed
consent or adherence to protocol.
15. Geographic inaccessibility for follow-up.
16. Inability to localize surgical cavity on CT (i.e., no evidence of surgical
clips or seroma).
17. Inability to adequately plan the patient for the experimental technique.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.
Outcome Time Frame:
ongoing throughout study
Safety Issue:
No
Principal Investigator
Tim Whelan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ontario Clinical Oncology Group / Juravinski Cancer Centre
Authority:
Canada: Health Canada
Study ID:
OCOG-2005-RAPID
NCT ID:
NCT00282035
Start Date:
January 2006
Completion Date:
July 2021
Related Keywords:
- Breast Cancer
- breast cancer
- breast tumour
- DCIS
- female
- breast conserving surgery
- irradiation
- whole breast irradiation
- 3D CRT accelerated partial breast irradiation
- cosmetic outcome
- quality of life
- Breast Neoplasms
- Carcinoma, Intraductal, Noninfiltrating
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