Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00310167
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2006-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 614}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2006-03-29', 'studyFirstSubmitQcDate': '2006-03-29', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local progression-free interval in irradiated field', 'timeFrame': 'up to 5 years after randomisation', 'description': 'Time form randomisation to tumour progression within the irradiated field'}], 'secondaryOutcomes': [{'measure': 'Acute toxicity', 'timeFrame': 'at 4 weeks after randomization'}, {'measure': 'Late toxicity', 'timeFrame': 'from 12 weeks after randomisation up to 5 years'}, {'measure': 'Tumor response in irradiated area at 12 weeks after randomization', 'timeFrame': 'at 12 weeks after randomization'}, {'measure': 'Overall survival', 'timeFrame': 'up to 5 years after randomisation'}, {'measure': 'Health economic assessment', 'timeFrame': 'up to 5 years after randomisation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I grade 1 follicular lymphoma', 'stage I grade 2 follicular lymphoma', 'stage I grade 3 follicular lymphoma', 'contiguous stage II grade 1 follicular lymphoma', 'noncontiguous stage II grade 1 follicular lymphoma', 'contiguous stage II grade 2 follicular lymphoma', 'noncontiguous stage II grade 2 follicular lymphoma', 'contiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'Marginal zone lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '33539729', 'type': 'DERIVED', 'citation': 'Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1.'}, {'pmid': '24572077', 'type': 'DERIVED', 'citation': 'Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkin's lymphoma.\n\nPURPOSE: This randomized phase III trial is studying two different regimens of low-dose radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Compare the local progression-free interval in patients with follicular non-Hodgkin's lymphoma (NHL) treated with 2 different regimens of low-dose radiotherapy.\n\nSecondary\n\n* Compare acute toxicity at 4 weeks in patients treated with these regimens.\n* Compare late toxicity in patients treated with these regimens.\n* Compare tumor response at 12 weeks in patients treated with these regimens.\n* Compare overall survival in patients treated with these regimens.\n* Assess the health economics of these regimens in these patients.\n\nOUTLINE: This is a multicenter, randomized study. Patients are randomized to one of two treatment arms.\n\n* Arm I 4Gy: Patients undergo low-dose radiotherapy once daily on days 1 and 2.\n* Arm II 24Gy: Patients undergo low-dose radiotherapy once daily on days 1-5, 8-12, 15, and 16.\n\nIn both arms, treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study therapy, patients are followed up for 5 years.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 650 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed follicular or mmarginal zone non-Hodgkin's lymphoma (NHL)\n\n * Any stage\n* Radiotherapy is indicated for curative treatment of stage IA or IIA disease OR palliation due to tumor bulk or anatomical position\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy \\> 3 months\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 4 weeks since prior chemotherapy"}, 'identificationModule': {'nctId': 'NCT00310167', 'acronym': 'FoRT', 'briefTitle': "Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma', 'orgStudyIdInfo': {'id': 'UCL/05/84'}, 'secondaryIdInfos': [{'id': 'CRUK-FORT'}, {'id': 'CRUK-BRD/05/84'}, {'id': '2005-002416-19', 'type': 'EUDRACT_NUMBER'}, {'id': 'ISRCTN65687030'}, {'id': 'EU-20601'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 Gy', 'description': '4 Gy in 2 fractions', 'interventionNames': ['Radiation: radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '24 Gy', 'description': '24 Gy in 12 fractions', 'interventionNames': ['Radiation: radiation therapy']}], 'interventions': [{'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['24 Gy', '4 Gy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W1T 4TJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research UK and University College London Cancer Trials Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}