Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00814567
Status:
UNKNOWN
Last Update Posted:
2019-02-27
First Post:
2008-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}], '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': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2018}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2008-12-24', 'studyFirstSubmitQcDate': '2008-12-24', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Location of tumor relapse', 'timeFrame': '5 years'}, {'measure': 'Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment', 'timeFrame': '5 years'}, {'measure': 'Regional and distant metastases', 'timeFrame': '5 years'}, {'measure': 'Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments', 'timeFrame': '5 years'}, {'measure': 'Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years', 'timeFrame': '5 years'}, {'measure': 'Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IA breast cancer', 'stage II breast cancer', 'invasive ductal breast carcinoma', 'invasive ductal breast carcinoma with predominant intraductal component'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28779963', 'type': 'BACKGROUND', 'citation': 'Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.'}, {'pmid': '30532984', 'type': 'BACKGROUND', 'citation': 'Bhattacharya IS, Haviland JS, Kirby AM, Kirwan CC, Hopwood P, Yarnold JR, Bliss JM, Coles CE; IMPORT Trialists. Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial. J Clin Oncol. 2019 Feb 1;37(4):305-317. doi: 10.1200/JCO.18.00982. Epub 2018 Dec 11.'}, {'pmid': '30236641', 'type': 'BACKGROUND', 'citation': 'Kirby AM, Bhattacharya IS, Wilcox M, Haviland JS. The IMPORT LOW Trial: Collaborative Research Accelerates Practice Change in Breast Radiotherapy. Clin Oncol (R Coll Radiol). 2019 Jan;31(1):5-8. doi: 10.1016/j.clon.2018.08.007. Epub 2018 Sep 17. No abstract available.'}, {'pmid': '17051947', 'type': 'BACKGROUND', 'citation': 'Coles C, Yarnold J; IMPORT Trials Management Group. The IMPORT trials are launched (September 2006). Clin Oncol (R Coll Radiol). 2006 Oct;18(8):587-90. doi: 10.1016/j.clon.2006.07.010. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.\n\nPURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.', 'detailedDescription': 'OBJECTIVES:\n\n* To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer.\n\nOUTLINE: This is a multicenter study.\n\nPatients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.\n* Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.\n* Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.\n\nAll patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays.\n\nPatients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years.\n\nAfter completion of study treatment, patients are followed for 10 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of low-risk early stage breast cancer, meeting the following criteria:\n\n * Invasive adenocarcinoma\n\n * No invasive carcinoma of classical lobular type\n * lympho-vascular invasion present or absent\n * Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (\\< 3.1 cm maximum microscopic diameter of invasive component)\n * Unifocal disease\n * Grade I, II, or III disease\n * Axillary lymph nodes negative or 1-3 nodes positive (pN0 or pN+(1-3))\n* Must have undergone breast conservation surgery with or without adjuvant systemic therapy\n\n * Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)\n* At low risk of local recurrence after radiotherapy (\\< 1% annual risk local recurrence)\n* No prior mastectomy\n* No blood-borne metastases\n\nPATIENT CHARACTERISTICS:\n\n* No prior malignancy except nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior endocrine therapy or chemotherapy\n\n * Neoadjuvant endocrine therapy allowed provided the tumour is \\< 3.0 cm and all other inclusion criteria are met\n * No primary endocrine therapy as a replacement for surgery\n* No concurrent chemoradiotherapy'}, 'identificationModule': {'nctId': 'NCT00814567', 'acronym': 'IMPORT', 'briefTitle': 'Radiation Therapy in Women With Low Risk Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer', 'orgStudyIdInfo': {'id': 'CDR0000629768'}, 'secondaryIdInfos': [{'id': 'NIHR 2253', 'type': 'OTHER', 'domain': 'NIHR'}, {'id': 'ICR-CTSU/2006/10001', 'type': 'OTHER', 'domain': 'ICR-CTSU'}, {'id': 'ISRCTN12852634', 'type': 'REGISTRY', 'domain': 'ISRCTN'}, {'id': 'CRUK/06/003', 'type': 'OTHER_GRANT', 'domain': 'Cancer Research UK'}, {'id': '06/Q1605/128', 'type': 'OTHER', 'domain': 'Main Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (control)', 'description': 'Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.', 'interventionNames': ['Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.', 'interventionNames': ['Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III', 'description': 'Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.', 'interventionNames': ['Radiation: radiation therapy']}], 'interventions': [{'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy', 'armGroupLabels': ['Arm I (control)', 'Arm II', 'Arm III']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Charlotte E Coles, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambrige, England'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}