3D conformal Radiation therapy for Accelerated Partial breast IrraDiation (RAPID) trial
| ISRCTN | ISRCTN62704822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62704822 |
| ClinicalTrials.gov number | NCT00282035 |
| Secondary identifying numbers | MCT-78567 |
- Submission date
- 24/06/2008
- Registration date
- 24/06/2008
- Last edited
- 08/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Timothy Joseph Whelan
Scientific
Scientific
Juravinski Cancer Centre
Supportive Cancer Care Research Unit
699 Concession Street, Rm. 4-204
Hamilton, Ontario
L8V 5C2
Canada
| Phone | +1 905 387 9711 ext. 64501 |
|---|---|
| tim.whelan@hrcc.on.ca |
Study information
| Study design | Multicentre two-arm non-inferiority randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 3D conformal Radiation therapy for Accelerated Partial breast IrraDiation (RAPID) trial |
| Study acronym | RAPID |
| Study hypothesis | Accelerated partial breast irradiation (APBI) is equivalent to whole breast irradiation. |
| Ethics approval(s) | Research Ethics Board of McMaster University, 23/12/2005, ref: 05-440. McMaster REB approved protocol amendment 1 with a revised ICF on 20/05/2008. |
| Condition | Breast cancer therapy |
| Intervention | 1. Control arm: whole breast irradiation 2. Experimental arm: accelerated partial breast irradiation using 3D conformal therapy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Timepoints added 18/11/2008: Ipsilateral breast or axillary recurrence, measured at any point throughout the trial. |
| Secondary outcome measures | Timepoints added 18/11/2008: 1. Cosmetic outcome, measured at 1, 3, 5 and 10 years 2. Radiation toxicity, acute at 2 weeks post radiation, late at 1, 3, 5, 10 years 3. Disease free survival, measured time from randomisation to time of documented recurrent disease 4. Event free survival, measured from time from randomisation to time of documented cancer or death 5. Overall survival, measured from time from randomisation to death 6. Quality of life, measured at 1, 3, 5, 10 years 7. Cost effectiveness, measured from a sample of 20% of trial population (treatment resources) |
| Overall study start date | 01/01/2006 |
| Overall study end date | 31/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2128 |
| Participant inclusion criteria | 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 |
| Participant exclusion criteria | 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 of cervix, endometrium, colon, and thyroid treated 5 years prior to study entry 10. Currently pregnant or lactating 11. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus [SLE], scleroderma) which preclude definitive radiation treatment 12. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol 13. Geographic inaccessibility for follow-up 14. Status for adjuvant systemic therapy not determined 15. Unable to commence radiation within 12 weeks of the last surgical procedure on the breast where the patient is not treated with adjuvant chemotherapy, or unable to commence within 8 weeks of the last dose of chemotherapy where the patient is treated with adjuvant chemotherapy |
| Recruitment start date | 01/01/2006 |
| Recruitment end date | 31/01/2014 |
Locations
Countries of recruitment
- Canada
Study participating centre
Juravinski Cancer Centre
Hamilton, Ontario
L8V 5C2
Canada
L8V 5C2
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Website | http://www.mcmaster.ca/ |
|---|---|
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78567)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 10/11/2013 | 14/02/2019 | Yes | No |
| Results article | 14/12/2019 | 08/06/2022 | Yes | No |
Editorial Notes
08/06/2022: Publication reference added.
14/02/2019: Publication reference added.
18/11/2008: This record has been updated due to a protocol amendment that took place earlier in the year (19/03/2008). Details of all changes to the trial information can be found in the relevant section, under the update date of 17/11/2008.
