3D conformal Radiation therapy for Accelerated Partial breast IrraDiation (RAPID) trial

ISRCTN	ISRCTN62704822
DOI	https://doi.org/10.1186/ISRCTN62704822
ClinicalTrials.gov (NCT)	NCT00282035
Protocol serial number	MCT-78567
Sponsor	McMaster University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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 of protocol

Not provided at time of registration

Contact information

Dr Timothy Joseph Whelan
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
Email	tim.whelan@hrcc.on.ca

Study information

Primary study design	Interventional
Study design	Multicentre two-arm non-inferiority randomised parallel trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	3D conformal Radiation therapy for Accelerated Partial breast IrraDiation (RAPID) trial
Study acronym	RAPID
Study objectives	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.
Health condition(s) or problem(s) studied	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(s)	Timepoints added 18/11/2008: Ipsilateral breast or axillary recurrence, measured at any point throughout the trial.
Key secondary outcome measure(s)	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)
Completion date	31/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	2128
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	31/01/2014

Locations

Countries of recruitment

Canada

Study participating centre

Juravinski Cancer Centre

Hamilton, Ontario
L8V 5C2
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		14/12/2019	08/06/2022	Yes	No
Interim results article	interim results	10/11/2013	14/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.