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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00282035
Registration number
NCT00282035
Ethics application status
Date submitted
23/01/2006
Date registered
25/01/2006
Date last updated
13/07/2018
Titles & IDs
Public title
RAPID: Randomized Trial of Accelerated Partial Breast Irradiation
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Scientific title
An RCT to Determine if APBI, Utilizing 3D CRT, is as Effective as Whole Breast Irradiation Following Breast Conserving Surgery in Women With Ductal Carcinoma in Situ or Invasive Breast Cancer With Negative Axillary Lymph Nodes
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Secondary ID [1]
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CIHR Grant Number: MCT-78567
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Secondary ID [2]
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OCOG-2005-RAPID
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - APBI utilizing 3D-CRT radiation
Treatment: Other - Whole breast irradiation
Experimental: APBI utilizing 3D-CRT radiation - Accelerated partial breast irradiation utilizing 3D-CRT
Other: Whole breast irradiation - Whole breast irradiation
Treatment: Other: APBI utilizing 3D-CRT radiation
Accelerated partial breast irradiation utilizing 3D-CRT
Treatment: Other: Whole breast irradiation
Whole breast irradiation
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.
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Assessment method [1]
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ipsilateral breast tumour recurrence
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Timepoint [1]
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ongoing throughout study
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Secondary outcome [1]
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adverse cosmetic outcome
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Assessment method [1]
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adverse cosmetic outcome
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Timepoint [1]
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evaluated at 1, 3, 5, 7 and 10 years
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Secondary outcome [2]
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disease free survival
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Assessment method [2]
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disease free survival
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Timepoint [2]
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ongoing throughout study
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Secondary outcome [3]
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event free survival
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Assessment method [3]
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event free survival
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Timepoint [3]
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ongoing throughout study
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Secondary outcome [4]
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overall survival
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Assessment method [4]
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overall survival
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Timepoint [4]
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ongoing throughout study
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Secondary outcome [5]
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radiation toxicity
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Assessment method [5]
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radiation toxicity
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Timepoint [5]
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ongoing throughout study
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Secondary outcome [6]
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quality of life based on questionnaire responses
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Assessment method [6]
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quality of life
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Timepoint [6]
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ongoing throughout study
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Secondary outcome [7]
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cost effectiveness
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Assessment method [7]
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cost effectiveness
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Timepoint [7]
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end of study
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Eligibility
Key inclusion criteria
- 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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2018
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Sample size
Target
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Accrual to date
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Final
2135
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Bendigo
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Box Hill
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin - Melbourne
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Recruitment postcode(s) [1]
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3550 - Bendigo
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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3165 - Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Manitoba
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Country [4]
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Canada
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State/province [4]
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New Brunswick
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Country [5]
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Canada
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State/province [5]
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Nova Scotia
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Canada
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State/province [7]
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Quebec
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Country [8]
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New Zealand
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State/province [8]
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Auckland Region
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ontario Clinical Oncology Group (OCOG)
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Canadian Breast Cancer Research Alliance
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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 ductal carcinoma in situ only or invasive breast cancer without
evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral
breast tumour recurrence.
General objective is to improve the convenience and quality of life of female patients who
receive breast irradiation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00282035
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tim Whelan, MD
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Address
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Ontario Clinical Oncology Group / Juravinski Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00282035
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