NCT00282035

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,135

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable breast-cancer

Geographic Reach
3 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

12.3 years

First QC Date

January 23, 2006

Last Update Submit

July 11, 2018

Conditions

Breast Cancer

Keywords

breast cancerbreast tumourDCISfemalebreast conserving surgeryirradiationwhole breast irradiation3D CRT accelerated partial breast irradiationcosmetic outcomequality of life

Outcome Measures

Primary Outcomes (1)

  • ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.

    ipsilateral breast tumour recurrence

    ongoing throughout study

Secondary Outcomes (7)

  • adverse cosmetic outcome

    evaluated at 1, 3, 5, 7 and 10 years

  • disease free survival

    ongoing throughout study

  • event free survival

    ongoing throughout study

  • overall survival

    ongoing throughout study

  • radiation toxicity

    ongoing throughout study

  • +2 more secondary outcomes

Study Arms (2)

APBI utilizing 3D-CRT radiation

EXPERIMENTAL

Accelerated partial breast irradiation utilizing 3D-CRT

Radiation: APBI utilizing 3D-CRT radiation

Whole breast irradiation

OTHER

Whole breast irradiation

Radiation: Whole breast irradiation

Interventions

APBI utilizing 3D-CRT radiationRADIATION

Accelerated partial breast irradiation utilizing 3D-CRT

APBI utilizing 3D-CRT radiation
Whole breast irradiationRADIATION

Whole breast irradiation

Whole breast irradiation

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a. Female patient with a new histological diagnosis of DCIS only. OR
  • b. Female patient with a new histological diagnosis of invasive carcinoma of the breast and no evidence of metastatic disease.
  • \. Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re- excision).
  • \. 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

You may not qualify if:

  • \. Age \< 40 years.
  • \. A known deleterious mutation in BRCA 1 and/or BRCA 2.
  • \. Tumour size \> 3 cm in greatest diameter on pathological examination (including both the invasive and non-invasive component).
  • \. Tumour histology limited to lobular carcinoma only.
  • \. 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.
  • \. More than one primary tumour in different quadrants of the same breast.
  • \. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation.
  • \. Presence of an ipsilateral breast implant or pacemaker.
  • \. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
  • \. Estrogen receptor status (ER) not known.
  • \. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast.
  • \. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Peter MacCallum Cancer Centre

Bendigo, Victoria, 3550, Australia

Location

Peter MacCallum Cancer Centre

Box Hill, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin

Melbourne, Victoria, 3165, Australia

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Agency - Abbotsford Centre

Abbotsford, British Columbia, V2S 0C2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

British Columbia Cancer Agency - Fraser Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

British Columbia Cancer Agency - Vancouver Island Centre

Vancouver, British Columbia, V8R 6V5, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

QE II HSC - Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Brantford General Hospital

Brantford, Ontario, N3R 1G9, Canada

Location

Northeastern Regional Cancer Centre

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Center

Mississauga, Ontario, L5M 2N1, Canada

Location

Durham Regional Cancer Centre - Lakeridge Health Corporation

Oshawa, Ontario, L1G 2B9, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Irving Greenberg Family Cancer Centre

Ottawa, Ontario, K2H 8P4, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2R 5K3, Canada

Location

Princess Margaret Hospital - University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUS - Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Hospital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

McGill University - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHUQ, L'Hotel Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

Location

Related Publications (1)

  • Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5.

    PMID: 31813635DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Tim Whelan, MD

    Ontario Clinical Oncology Group / Juravinski Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Ivo Olivotto, MD

    British Columbia Cancer Agency - Vancouver Island Centre

    PRINCIPAL INVESTIGATOR

  • Mark Levine, MD

    Ontario Clinical Oncology Group (OCOG)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 25, 2006

Study Start

January 1, 2006

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

CA(28)NZ(1)AU(4)