Status:
COMPLETED
RAPID: Randomized Trial of Accelerated Partial Breast Irradiation
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Research Alliance
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as Whole Breast Irradiation following breast conserving surgery in women with an new histological diagnosis of duc...
Detailed Description
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. Patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
2135 Patients enrolled
Trial Details
Trial ID
NCT00282035
Start Date
January 1 2006
End Date
March 31 2018
Last Update
July 13 2018
Active Locations (33)
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1
Peter MacCallum Cancer Centre
Bendigo, Victoria, Australia, 3550
2
Peter MacCallum Cancer Centre
Box Hill, Victoria, Australia, 3128
3
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
4
Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin
Melbourne, Victoria, Australia, 3165