Condition category
Cancer
Date applied
24/06/2008
Date assigned
24/06/2008
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy Joseph Whelan

ORCID ID

Contact details

Juravinski Cancer Centre
Supportive Cancer Care Research Unit
699 Concession Street
Rm. 4-204
Hamilton
Ontario
L8V 5C2
Canada
+1 905 387 9711 ext. 64501
tim.whelan@hrcc.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00282035

Protocol/serial number

MCT-78567

Study information

Scientific title

Acronym

RAPID

Study hypothesis

Accelerated partial breast irradiation (APBI) is equivalent to whole breast irradiation.

Please note that as of 18/11/2008 this record has been updated due to a protocol amendment that took place earlier in the year (19 March 2008). Details of all changes to the trial information can be found in the relevant section, under the update date of 17/11/2008.

Ethics approval

Ethics approval received from the Research Ethics Board of McMaster University on the 23rd December 2005 (ref: 05-440). McMaster REB approved protocol amendment 1 with a revised ICF on 20th May 2008.

Study design

Multicentre, two arm, non-inferiority, randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer therapy

Intervention

1. Control arm: whole breast irradiation
2. Experimental arm: accelerated partial breast irradiation using 3D conformal therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

2128

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

Trial participating centre

Juravinski Cancer Centre
Hamilton, Ontario
L8V 5C2
Canada

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada

Sponsor type

University/education

Website

http://www.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78567)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes