3D conformal Radiation therapy for Accelerated Partial breast IrraDiation (RAPID) trial
- Conditions
- Breast cancer therapyCancerMalignant neoplasm of the breast
- Registration Number
- ISRCTN62704822
- Lead Sponsor
- McMaster University (Canada)
- Brief Summary
2013 Interim results article in http://ascopubs.org/doi/full/10.1200/JCO.2013.50.5511 interim results (added 14/02/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31813635/ (added 08/06/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 2128
Modifications as of 18/11/2008: point three of the inclusion criteria has been updated as follows:
3. Negative axillary node involvement including micrometastasis less than or equal to 0.2 mm or positive cells only identified by immunohistochemistry (IHC) as determined by:
3.1. Sentinel node biopsy
3.2. Axillary node dissection
3.3. Clinical exam for patients with DCIS only
Initial information at time of registration:
1. Female patients, 40 years and older, with a new histological diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast with no evidence of metastatic disease
2. Treated by breast-conserving surgery (BCS) with microscopically clear resection margins (or no residual disease on re-excision) and considered a candidate for breast irradiation
3. Negative axillary node involvement determined by sentinel node biopsy, axillary node dissection or clinical exam in women greater than 70 years of age
Modifications as of 18/11/2008: the exclusion criteria have been updated as follows:
1. Aged less than 40 years
2. A known deleterious mutation in BRCA 1 and/or BRCA 2
3. Tumour size greater than 3 cm in greatest diameter on pathological examination (including both invasive and non-invasive components)
4. Tumour histology limited to lobular carcinoma only
5. Bilateral invasive or non-invasive malignancy of the breast (synchronous or metachronous)
6. More than one primary tumour in different quadrants of the same breast
7. Previous irradiation to the ipsilateral breast that would preclude WBI
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. Oestrogen 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. History of cancer:
13.1. Patients with another active malignancy or malignancy treated less than 5 years prior to randomisation are excluded with the exception of prior non-invasive contralateral breast cancer
13.2. Patients with a prior diagnosis of invasive breast cancer in either breast are excluded regardless of disease free interval
13.3. Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial
14. Currently pregnant or lactating
15. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol
16. Geographic inaccessibility for follow-up
17. Inability to localise surgical cavity on CT (i.e., no evidence of surgical clips or seroma)
18. Inability to adequately plan the patient for the experimental technique. The Dose Evaluation Volume (DEV) should be less than or equal to 25% of the total breast volume, or less than or equal to 35% whilst meeting other criteria mentioned in full in the protocol.
Initial information at time of registration:
1. Any patient with known breast cancer genes (BRCA 1 or 2)
2. Aged less than 40 years
3. Tumour greater than 3 cm in greatest diameter on pathological examination
4. Tumour histology involving lobular carcinoma
5. Inability to localise surgical cavity on computed tomography (CT) (i.e., no evidence of surgical clips or seroma)
6. Inability to adequately plan the patient for the experimental technique; seroma should be less than 25% of the total breast volume
7. Bilateral invasive malignancy of the breast (synchronous or metachronous)
8. More than one primary tumour in different quadrants of the same breast
9. Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, contralateral non-invasive breast cancer, and invasive carcinomas o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Timepoints added 18/11/2008:<br> Ipsilateral breast or axillary recurrence, measured at any point throughout the trial.<br>
- Secondary Outcome Measures
Name Time Method <br> Timepoints added 18/11/2008:<br> 1. Cosmetic outcome, measured at 1, 3, 5 and 10 years<br> 2. Radiation toxicity, acute at 2 weeks post radiation, late at 1, 3, 5, 10 years<br> 3. Disease free survival, measured time from randomisation to time of documented recurrent disease<br> 4. Event free survival, measured from time from randomisation to time of documented cancer or death<br> 5. Overall survival, measured from time from randomisation to death<br> 6. Quality of life, measured at 1, 3, 5, 10 years<br> 7. Cost effectiveness, measured from a sample of 20% of trial population (treatment resources)<br>