Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT03374592
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resource utilization', 'timeFrame': 'Baseline', 'description': 'Time spent in planning and delivering radiotherapy'}, {'measure': 'Physical activity', 'timeFrame': '1 week', 'description': 'Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker'}, {'measure': 'Blood biomarkers', 'timeFrame': '1 week', 'description': 'Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy'}, {'measure': 'Blood biomarkers', 'timeFrame': '1 week', 'description': 'Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy'}], 'primaryOutcomes': [{'measure': 'Quality of Life (QOL)', 'timeFrame': '1 week', 'description': 'The global QOL subscale will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. The global QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). Higher scores represent better global QOL.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life - Function subscales', 'timeFrame': '3 month', 'description': 'Quality of life function subscales (physical, role, cognitive, emotional, social and financial functions) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For function subscales, higher scores represent better function.'}, {'measure': 'Quality of Life - Symptom subscales', 'timeFrame': '3 month', 'description': 'Quality of life symptom subscales (dyspnea, pain, fatigue, appetite loss, nausea, constipation, and diarrhea symptoms) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For symptom subscales, higher scores represent worse symptoms.'}, {'measure': 'Pain relief', 'timeFrame': '1 week', 'description': 'Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions'}, {'measure': 'Pain relief', 'timeFrame': '1 month', 'description': 'Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions'}, {'measure': 'Pain relief', 'timeFrame': '3 month', 'description': 'Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions'}, {'measure': 'Toxicities', 'timeFrame': '1 week', 'description': 'Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4'}, {'measure': 'Toxicities', 'timeFrame': '1 month', 'description': 'Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4'}, {'measure': 'Toxicities', 'timeFrame': '3 month', 'description': 'Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensity-modulated radiation therapy', 'Volumetric intensity-modulated arc therapy', 'Radiotherapy', 'Pain', 'Metastasis', 'Quality of Life', 'Acute Toxicity'], 'conditions': ['Neoplasm Metastasis', 'Pain', 'Radiotherapy Side Effect', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '33259935', 'type': 'RESULT', 'citation': 'Wong P, Lambert L, Thanomsack P, Coulombe G, Lambert C, Charpentier AM, Barkati M, Fortin I, Lafontaine J, Roberge D. Quality of Life: A Prospective Randomized Trial of Palliative Volumetric Arc Therapy Versus 3-Dimensional Conventional Radiation Therapy. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1431-1439. doi: 10.1016/j.ijrobp.2020.11.061. Epub 2020 Nov 28.'}, {'pmid': '29383293', 'type': 'RESULT', 'citation': 'Dorion V, Lambert L, Frazzi A, Cayer JF, Wong P. A Pilot Study in the Use of Activity Trackers for Assessing Response to Palliative Radiotherapy. Cureus. 2017 Nov 22;9(11):e1871. doi: 10.7759/cureus.1871.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the use of conventional radiotherapy technique with volumetric intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half of the patients will receive radiotherapy using a conventional technique, while the other half will receive their treatment using a the VMAT technique.', 'detailedDescription': 'Radiotherapy to painful sites of metastasis can provide pain relief.\n\nSide-effects from radiotherapy is dependent on the volume and dose received by normal tissues. Conventional radiotherapy techniques delivers similar doses of radiation to the targeted cancer lesion and the normal tissues along the entrance and exit paths of the radiation.\n\nVolumetric intensity-modulated arc therapy (VMAT) is an advanced technique of radiotherapy that spares normal tissues from receiving high-dose irradiation. However, VMAT increases the volume of normal tissues receiving low-dose irradiation.\n\nThis study aims at comparing the quality of life and side-effect profiles of patients treated by palliative radiotherapy using the conventional technique vs. VMAT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself\n2. Capable of providing the full list of analgesic medication being used\n3. Capable of completing the SF-BPI and EORTC questionnaires without any help\n4. Life expectancy of at least 3 month\n5. KPS greater or equal to 50\n6. Radiotherapy to 1 site pain\n7. Site of treatment not previously irradiated\n8. No planned changes in analgesic within 7 days before and after treatment\n\n • Patient may be started on Dexamethasone on the first day of radiotherapy\n9. No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment\n10. Patient provided informed consent to participate in this study\n\nExclusion Criteria:\n\n1. Major mental or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.\n2. Treatment to upper and lower limb\n3. Treatment to 2 or more sites of pain\n4. Re-irradiation of the site of treatment\n5. Women who are pregnant\n6. Life expectancy less than 3 month"}, 'identificationModule': {'nctId': 'NCT03374592', 'briefTitle': 'Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain', 'orgStudyIdInfo': {'id': 'CE14.046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Radiotherapy', 'description': '8Gy in 1 fraction or 20Gy in 5 fractions', 'interventionNames': ['Radiation: Conventional Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Volumetric Intensity-Modulated Arc Therapy', 'description': '8Gy in 1 fraction or 20Gy in 5 fractions', 'interventionNames': ['Radiation: Volumetric Intensity-Modulated Arc Therapy']}], 'interventions': [{'name': 'Volumetric Intensity-Modulated Arc Therapy', 'type': 'RADIATION', 'otherNames': ['Intensity modulated radiotherapy'], 'description': 'Advanced radiotherapy technique', 'armGroupLabels': ['Volumetric Intensity-Modulated Arc Therapy']}, {'name': 'Conventional Radiotherapy', 'type': 'RADIATION', 'description': 'Conventional radiotherapy technique', 'armGroupLabels': ['Conventional Radiotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philip Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}