Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT04075058
Status:
COMPLETED
Last Update Posted:
2021-06-23
First Post:
2015-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiation Therapy in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1070}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Recurrence', 'timeFrame': '5 years', 'description': 'Any recurrence with in the irradiated area from completion of radiation'}], 'secondaryOutcomes': [{'measure': 'Acute skin toxicity', 'timeFrame': 'After 1 month of completion of radiation', 'description': 'Acute toxicity will be assessed using a RTOG grading system. Assessment will be carried out weekly during radiotherapy and for 4 weeks after treatment.'}, {'measure': 'Cosmetic assessment', 'timeFrame': 'Baseline, 1 year, 3 years, 5 years', 'description': 'done using Harvard/National Surgical Adjuvant Bowel and Breast Project(NSABP)/Radiation Therapy Oncology Group(RTOG) breast cosmesis grading scale. Grading will be done as Excellent- no or minimal difference between two breasts,Good- slight difference between two breasts,Good- slight and Fair minimal difference between two breasts, Fair- obvious difference between two breasts Poor- marked difference between two breasts. Excellent/good and fair/poor will be considered better and worse outcomes, respectively.'}, {'measure': 'Quality of life', 'timeFrame': '3 year, 5 year', 'description': 'EORTC QLQ -30 The QLQ-C30 is composed of both multi-item scales and single-item measures, as well as five functional scales, three symptom scales, a global health status/QoL scale, and six single items.The scores must be averaged and linearly transformed to obtain a range of scores from 0 to 100, with a higher score representing a greater response level. Thus, a high score for a functional scale represents a healthy level of functioning and a high score for the global health status represents a high QoL, but a high score for the symptom scale represents a high level of symptomatology.'}, {'measure': 'Quality of life', 'timeFrame': '3 year, 5 year', 'description': 'EORTC QLQ-BR 23 It contains 23 items rated on a four-point scale ranging from 1 (not at all) to 4 (very much). The items assess the side effects of therapy, arm symptoms, breast symptoms, body image, and sexual function. Additionally, there are single items assessing sexual enjoyment, anxiety caused by hair loss, and future outlook. The scores range between 0-100 points. For scales evaluating function, a higher score represents a higher level of functioning. For scales evaluating symptoms, a higher score indicates more severe symptoms.'}, {'measure': 'Disease free survival', 'timeFrame': '5 years, 10 years', 'description': 'Time interval free from locoregional recurrence and metastasis'}, {'measure': 'Overall survival', 'timeFrame': '5 years, 10 years', 'description': 'From the date of diagnosis to death'}, {'measure': 'Arm edema', 'timeFrame': '3 years, 5 years, 10 years', 'description': 'Will be graded by measuring arm circumference 10cm above and below the medial epicondyle of humerus. Treated side will be compared with the untreated opposite side as a reference. It will be classified as none, mild, moderate and marked if there was no difference, 0.5-2cm, 2.1-3cm and \\>3cm difference, respectively in the circumference of the affected and normal arm.'}, {'measure': 'Late effects- pain, shoulder stiffness', 'timeFrame': '3 years, 5 years, 10 years', 'description': 'A four point scale(none, a little, quite a bit, very much ) will be used to asess all late effects according to the RTOG LENT SOMA scale(Cox et al, 1995).'}, {'measure': 'Late effects- Brachial plexopathy', 'timeFrame': '3 years, 5 years, 10 years', 'description': 'If the patient had symptoms of pain in the arm, paresthesia, numbness, weakness, or other sensory symptoms then injury to the brachial plexus will be suspected and reported as brachial plexopathy.'}, {'measure': 'Late effects- Lung, cardiac', 'timeFrame': '5 years, 10 years', 'description': 'Late lung and cardiac toxicity asess all late effects according to the RTOG LENT SOMA scale (Cox et al, 1995).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'hypofractionated radiotherapy', 'Hypofractionated radiation'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '17963907', 'type': 'BACKGROUND', 'citation': 'Yadav BS. Accelerated partial breast irradiation. Radiother Oncol. 2009 Jan;90(1):161. doi: 10.1016/j.radonc.2007.10.005. Epub 2007 Oct 25. No abstract available.'}, {'pmid': '17961777', 'type': 'BACKGROUND', 'citation': 'Yadav BS, Sharma SC, Patel FD, Ghoshal S, Kapoor RK. Second primary in the contralateral breast after treatment of breast cancer. Radiother Oncol. 2008 Feb;86(2):171-6. doi: 10.1016/j.radonc.2007.10.002. Epub 2007 Oct 24.'}, {'pmid': '25022378', 'type': 'RESULT', 'citation': 'Yadav BS, Sharma SC, George P, Bansal A. Post-mastectomy radiation beyond chest wall in patients with N1 breast cancer: is there a benefit? J Cancer Res Ther. 2014 Apr-Jun;10(2):279-83. doi: 10.4103/0973-1482.136560.'}, {'pmid': '18804919', 'type': 'RESULT', 'citation': 'Yadav BS, Sharma SC, Patel FD, Ghoshal S, Kapoor R, Kumar R. Nonbreast second malignancies after treatment of primary breast cancer. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1489-92. doi: 10.1016/j.ijrobp.2008.07.004. Epub 2008 Sep 19.'}, {'pmid': '38550605', 'type': 'DERIVED', 'citation': 'Yadav BS, Dahiya D, Gupta M, Gupta A, Oinam AS, Khare S, Irrinki S, Robert N, Sakaray YR, Nagaraj SS, Kumari R. Preliminary results of hypofractionated radiotherapy in breast cancer in Chandigarh, India: single-centre, non-inferiority, open-label, randomised, phase 3 trial. Lancet Reg Health Southeast Asia. 2024 Mar 21;24:100392. doi: 10.1016/j.lansea.2024.100392. eCollection 2024 May.'}]}, 'descriptionModule': {'briefSummary': 'The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 1000 patients, 500 in each arm, with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks in the study arm and 35Gy in 15 fractions over 3 weeks in the control arm. The primary endpoint of the study will be ipsilateral local tumour control. Secondary endpoints will be early and late adverse effects in normal tissues, quality of life, contralateral primary tumours, regional and distant metastases and survival.', 'detailedDescription': 'Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I-III of breast carcinoma. Total 500 patients of histologically proven post lumpectomy/mastectomy cases of carcinoma breast suitable for radiotherapy will be enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER, Chandigarh by doing a thorough clinical examination followed by routine investigations which will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients will be treated by standard rectangular tangential fields.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive carcinoma of the breast\n* Breast conservation surgery or mastectomy\n* Axillary staging \\&/or dissection\n* Complete microscopic excision of primary tumour\n* pT1-3 pN0-2 M0 disease\n* Written informed consent\n* Able to comply with follow up\n\nExclusion Criteria:\n\n* Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free\n* Contralateral breast cancer, including DCIS, irrespective of date of diagnosis\n* Breast reconstruction using implants\n* Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)'}, 'identificationModule': {'nctId': 'NCT04075058', 'acronym': 'HRBC', 'briefTitle': 'Hypofractionated Radiation Therapy in Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'A Phase III Randomized Study Comparing Two Adjuvant Hypofractionated Radiation Schedules in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': 'HRBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'Patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a hypofractionated radiotherapy dose of 34Gy in 10 fractions over 2 weeks.', 'interventionNames': ['Radiation: Hypofractionated Radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a hypofractionated radiotherapy dose of 35Gy in 15 fractions over 3 weeks', 'interventionNames': ['Radiation: Hypofractionated Radiation therapy']}], 'interventions': [{'name': 'Hypofractionated Radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Control', 'Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91 160012', 'city': 'Chandigarh', 'state': 'N/A = Not Applicable', 'country': 'India', 'facility': 'Dr Budhi Singh Yadav', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Budhi S Yadav, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PGIMER, Chandigarh, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor', 'investigatorFullName': 'Dr Budhi Singh Yadav', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}