Spots Global Cancer Trial Database for RAPID: Randomized Trial of Accelerated Partial Breast Irradiation
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Trial Identification
Brief Title: RAPID: Randomized Trial of Accelerated Partial Breast Irradiation
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 ID: NCT00282035
Conditions
Study Description
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.
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.
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Peter MacCallum Cancer Centre, Bendigo, Victoria, Australia
Peter MacCallum Cancer Centre, Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin, Melbourne, Victoria, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Agency - Abbotsford Centre, Abbotsford, British Columbia, Canada
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Centre, Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre, Vancouver, British Columbia, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada
QE II HSC - Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Brantford General Hospital, Brantford, Ontario, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Center, Mississauga, Ontario, Canada
Durham Regional Cancer Centre - Lakeridge Health Corporation, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Irving Greenberg Family Cancer Centre, Ottawa, Ontario, Canada
Niagara Health System, St. Catharines, Ontario, Canada
Northeastern Regional Cancer Centre, Sudbury, Ontario, Canada
Princess Margaret Hospital - University Health Network, Toronto, Ontario, Canada
Windsor Regional Cancer centre, Windsor, Ontario, Canada
CHUS - Hopital Fleurimont, Fleurimont, Quebec, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
CHUM - Hospital Notre Dame, Montreal, Quebec, Canada
McGill University - Montreal General Hospital, Montreal, Quebec, Canada
McGill University - Jewish General Hospital, Montreal, Quebec, Canada
CHUQ, L'Hotel Dieu de Quebec, Quebec City, Quebec, Canada
Auckland City Hospital, Auckland, Auckland Region, New Zealand
Contact Details
Name: Tim Whelan, MD
Affiliation: Ontario Clinical Oncology Group / Juravinski Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Ivo Olivotto, MD
Affiliation: British Columbia Cancer Agency - Vancouver Island Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: STUDY_DIRECTOR
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