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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CIHR Grant Number: MCT-78567
Secondary ID [2] 0 0
OCOG-2005-RAPID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.
Timepoint [1] 0 0
ongoing throughout study
Secondary outcome [1] 0 0
adverse cosmetic outcome
Timepoint [1] 0 0
evaluated at 1, 3, 5, 7 and 10 years
Secondary outcome [2] 0 0
disease free survival
Timepoint [2] 0 0
ongoing throughout study
Secondary outcome [3] 0 0
event free survival
Timepoint [3] 0 0
ongoing throughout study
Secondary outcome [4] 0 0
overall survival
Timepoint [4] 0 0
ongoing throughout study
Secondary outcome [5] 0 0
radiation toxicity
Timepoint [5] 0 0
ongoing throughout study
Secondary outcome [6] 0 0
quality of life based on questionnaire responses
Timepoint [6] 0 0
ongoing throughout study
Secondary outcome [7] 0 0
cost effectiveness
Timepoint [7] 0 0
end of study

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
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2018
Sample size
Target
Accrual to date
Final
2135
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Bendigo
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Box Hill
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin - Melbourne
Recruitment postcode(s) [1] 0 0
3550 - Bendigo
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3165 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland Region

Funding & Sponsors
Primary sponsor type
Other
Name
Ontario Clinical Oncology Group (OCOG)
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Breast Cancer Research Alliance
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tim Whelan, MD
Address 0 0
Ontario Clinical Oncology Group / Juravinski Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00282035