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Trial record 1 of 3 for:    accelerated partial breast radiation AND Rapid
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RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282035
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: APBI utilizing 3D-CRT radiation Radiation: Whole breast irradiation Not Applicable

Detailed Description:

Following breast conserving surgery or on completion of chemotherapy, patients will be stratified according to age, tumour histology, tumour size, adjuvant hormonal therapy and clinical centre. Patients will be allocated to receive either whole breast irradiation or 3D CRT accelerated partial breast irradiation.

Radiation therapy will be administered as soon as possible following the healing of the surgical incision (3-4 weeks) and within 12 weeks if the patient is not treated with chemotherapy. If the patient is treated with chemotherapy, radiation therapy will begin after 2 weeks and not beyond 8 weeks after the last dose of chemotherapy.

Patients treated with whole breast irradiation will receive a total dose of 42.5 Gy in 16 fractions, given on a daily basis, over a time period of 22 days. Patients with large breast size are permitted to receive a total dose of 50 Gy in 25 fractions, given on a daily basis, over a time period of 35 days. Boost irradiation is permitted in patients treated with whole breast irradiation. Boost irradiation of 10 Gy/4-5 fractions daily over a time period of 4-7 days is permitted for patients deemed at moderate to high risk of local recurrence as per local cancer centre guidelines.

Patients treated with 3D CRT accelerated partial breast irradiation will receive a total dose of 38.5 Gy in 10 fractions, delivered twice a day, over a time period of 5-8 days. Each daily dose must be separated by 6-8 hours.

Patients will be followed indefinitely and assessed formally at 6 and 12 months after the date of randomization and then on a yearly basis. Patients will be assessed for acute and late radiation toxicity, cardiac toxicity, recurrent disease, new primary cancer, cosmetic outcome, quality of life and overall survival.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2006
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: APBI utilizing 3D-CRT radiation
Accelerated partial breast irradiation utilizing 3D-CRT
Radiation: APBI utilizing 3D-CRT radiation
Accelerated partial breast irradiation utilizing 3D-CRT

Whole breast irradiation
Whole breast irradiation
Radiation: Whole breast irradiation
Whole breast irradiation




Primary Outcome Measures :
  1. ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. [ Time Frame: ongoing throughout study ]
    ipsilateral breast tumour recurrence


Secondary Outcome Measures :
  1. adverse cosmetic outcome [ Time Frame: evaluated at 1, 3, 5, 7 and 10 years ]
    adverse cosmetic outcome

  2. disease free survival [ Time Frame: ongoing throughout study ]
    disease free survival

  3. event free survival [ Time Frame: ongoing throughout study ]
    event free survival

  4. overall survival [ Time Frame: ongoing throughout study ]
    overall survival

  5. radiation toxicity [ Time Frame: ongoing throughout study ]
    radiation toxicity

  6. quality of life based on questionnaire responses [ Time Frame: ongoing throughout study ]
    quality of life

  7. cost effectiveness [ Time Frame: end of study ]
    cost effectiveness



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282035


Locations
Hide Hide 33 study locations
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Australia, Victoria
Peter MacCallum Cancer Centre
Bendigo, Victoria, Australia, 3550
Peter MacCallum Cancer Centre
Box Hill, Victoria, Australia, 3128
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin
Melbourne, Victoria, Australia, 3165
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency - Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Centre
Vancouver, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
QE II HSC - Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Brantford General Hospital
Brantford, Ontario, Canada, N3R 1G9
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Center
Mississauga, Ontario, Canada, L5M 2N1
Durham Regional Cancer Centre - Lakeridge Health Corporation
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Irving Greenberg Family Cancer Centre
Ottawa, Ontario, Canada, K2H 8P4
Niagara Health System
St. Catharines, Ontario, Canada, L2R 5K3
Northeastern Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Hospital - University Health Network
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CHUS - Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUM - Hospital Notre Dame
Montreal, Quebec, Canada, H2L 4M1
McGill University - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
McGill University - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CHUQ, L'Hotel Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
New Zealand
Auckland City Hospital
Auckland, Auckland Region, New Zealand, 1023
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Research Alliance
Investigators
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Principal Investigator: Tim Whelan, MD Ontario Clinical Oncology Group / Juravinski Cancer Centre
Principal Investigator: Ivo Olivotto, MD British Columbia Cancer Agency - Vancouver Island Centre
Study Director: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00282035    
Other Study ID Numbers: OCOG-2005-RAPID
CIHR Grant Number: MCT-78567 ( Other Grant/Funding Number: CIHR )
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Keywords provided by Ontario Clinical Oncology Group (OCOG):
breast cancer
breast tumour
DCIS
female
breast conserving surgery
irradiation
whole breast irradiation
3D CRT accelerated partial breast irradiation
cosmetic outcome
quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases