Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT00282035
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2006-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RAPID: Randomized Trial of Accelerated Partial Breast Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2006-01-23', 'studyFirstSubmitQcDate': '2006-01-23', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.', 'timeFrame': 'ongoing throughout study', 'description': 'ipsilateral breast tumour recurrence'}], 'secondaryOutcomes': [{'measure': 'adverse cosmetic outcome', 'timeFrame': 'evaluated at 1, 3, 5, 7 and 10 years', 'description': 'adverse cosmetic outcome'}, {'measure': 'disease free survival', 'timeFrame': 'ongoing throughout study', 'description': 'disease free survival'}, {'measure': 'event free survival', 'timeFrame': 'ongoing throughout study', 'description': 'event free survival'}, {'measure': 'overall survival', 'timeFrame': 'ongoing throughout study', 'description': 'overall survival'}, {'measure': 'radiation toxicity', 'timeFrame': 'ongoing throughout study', 'description': 'radiation toxicity'}, {'measure': 'quality of life based on questionnaire responses', 'timeFrame': 'ongoing throughout study', 'description': 'quality of life'}, {'measure': 'cost effectiveness', 'timeFrame': 'end of study', 'description': 'cost effectiveness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'breast tumour', 'DCIS', 'female', 'breast conserving surgery', 'irradiation', 'whole breast irradiation', '3D CRT accelerated partial breast irradiation', 'cosmetic outcome', 'quality of life'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31813635', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nGeneral objective is to improve the convenience and quality of life of female patients who receive breast irradiation.', 'detailedDescription': '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.\n\nRadiation 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.\n\nPatients 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.\n\nPatients 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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1a. Female patient with a new histological diagnosis of DCIS only. OR\n\n 1b. Female patient with a new histological diagnosis of invasive carcinoma of the breast and no evidence of metastatic disease.\n\n 2\\. Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re- excision).\n\n 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\n\nExclusion Criteria:\n\n* 1\\. Age \\< 40 years.\n\n 2\\. A known deleterious mutation in BRCA 1 and/or BRCA 2.\n\n 3\\. Tumour size \\> 3 cm in greatest diameter on pathological examination (including both the invasive and non-invasive component).\n\n 4\\. Tumour histology limited to lobular carcinoma only.\n\n 5\\. History of cancer:\n * Patients with another active malignancy or malignancy treated \\< 5 years prior to randomization are excluded.\n * 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.\n * Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial.\n\n 6\\. More than one primary tumour in different quadrants of the same breast.\n\n 7\\. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation.\n\n 8\\. Presence of an ipsilateral breast implant or pacemaker.\n\n 9\\. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.\n\n 10\\. Estrogen receptor status (ER) not known.\n\n 11\\. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast.\n\n 12\\. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy.\n\n 13\\. Currently pregnant or lactating.\n\n 14\\. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.\n\n 15\\. Geographic inaccessibility for follow-up.\n\n 16\\. Inability to localize surgical cavity on CT (i.e., no evidence of surgical clips or seroma).\n\n 17\\. Inability to adequately plan the patient for the experimental technique.'}, 'identificationModule': {'nctId': 'NCT00282035', 'briefTitle': 'RAPID: Randomized Trial of Accelerated Partial Breast Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'Ontario Clinical Oncology Group (OCOG)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OCOG-2005-RAPID'}, 'secondaryIdInfos': [{'id': 'CIHR Grant Number: MCT-78567', 'type': 'OTHER_GRANT', 'domain': 'CIHR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APBI utilizing 3D-CRT radiation', 'description': 'Accelerated partial breast irradiation utilizing 3D-CRT', 'interventionNames': ['Radiation: APBI utilizing 3D-CRT radiation']}, {'type': 'OTHER', 'label': 'Whole breast irradiation', 'description': 'Whole breast irradiation', 'interventionNames': ['Radiation: Whole breast irradiation']}], 'interventions': [{'name': 'APBI utilizing 3D-CRT radiation', 'type': 'RADIATION', 'description': 'Accelerated partial breast irradiation utilizing 3D-CRT', 'armGroupLabels': ['APBI utilizing 3D-CRT radiation']}, {'name': 'Whole breast irradiation', 'type': 'RADIATION', 'description': 'Whole breast irradiation', 'armGroupLabels': ['Whole breast irradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3550', 'city': 'Bendigo', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -36.75818, 'lon': 144.28024}}, {'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3165', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V2S 0C2', 'city': 'Abbotsford', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency - Abbotsford Centre', 'geoPoint': {'lat': 49.05798, 'lon': -122.25257}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Centre for the Southern Interior', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Fraser Valley Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 6V5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Island Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Cancer Care Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Atlantic Health Sciences Corporation', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QE II HSC - Nova Scotia Cancer Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'N3R 1G9', 'city': 'Brantford', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brantford General Hospital', 'geoPoint': {'lat': 43.1334, 'lon': -80.26636}}, {'zip': 'P3E 5J1', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northeastern Regional Cancer Centre', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Regional Cancer Centre', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5M 2N1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Center', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Durham Regional Cancer Centre - Lakeridge Health Corporation', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K2H 8P4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Irving Greenberg Family Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L2R 5K3', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Niagara Health System', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital - University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Cancer centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'J1H 5N4', 'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUS - Hopital Fleurimont', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Hospital Notre Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University - Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University - Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "CHUQ, L'Hotel Dieu de Quebec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '1023', 'city': 'Auckland', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Tim Whelan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ontario Clinical Oncology Group / Juravinski Cancer Centre'}, {'name': 'Ivo Olivotto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Cancer Agency - Vancouver Island Centre'}, {'name': 'Mark Levine, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ontario Clinical Oncology Group (OCOG)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ontario Clinical Oncology Group (OCOG)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Canadian Breast Cancer Research Alliance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}