Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-05 @ 8:01 PM
Study NCT ID:
NCT01894633
Status:
TERMINATED
Last Update Posted:
2024-01-24
First Post:
2013-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002738', 'term': 'Chloroquine'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'whyStopped': 'terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2013-06-29', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life in brain metastases', 'timeFrame': 'The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.', 'description': 'The 30-item EORTC Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) version 3.0 (Mexican version) was used in this trial. The EORTC QLQ-C30 v3 consisted of five multi-item functional scales, three symptom scales, a global health status/QoL scale, and six single items'}], 'primaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'Every third month after randomization until 24 months follow-up. Measured by brain MRI', 'description': 'Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria'}], 'secondaryOutcomes': [{'measure': 'Central Nervous System Progression Free Survival', 'timeFrame': 'From time to progression to 24 months follow up', 'description': 'Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prophylactic Cranial Irradiation', 'Metastasis', 'Cloroquine'], 'conditions': ['Brain Metastasis']}, 'descriptionModule': {'briefSummary': 'Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.', 'detailedDescription': 'Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '46 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years of age\n* At leat one brain metastasis MRI\n* KPS 70 or more\n* RTOG-RPA I or II\n* Basic Laboratory requirements\n\nExclusion Criteria:\n\n* Candidates for radiosurgery, neurosurgery\n* Patients treated with radiotherapy before entered to the study'}, 'identificationModule': {'nctId': 'NCT01894633', 'acronym': 'CLQ', 'briefTitle': 'Study of Whole-brain Irradiation With Chloroquine for Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cancerologia de Mexico'}, 'officialTitle': 'Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.', 'orgStudyIdInfo': {'id': 'CD-449-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chloroquine, radiosensitizer', 'description': 'The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.', 'interventionNames': ['Drug: Chloroquine', 'Radiation: Total brain radiotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days', 'interventionNames': ['Radiation: Total brain radiotherapy']}], 'interventions': [{'name': 'Chloroquine', 'type': 'DRUG', 'otherNames': ['Aralen'], 'description': 'The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days', 'armGroupLabels': ['Chloroquine, radiosensitizer']}, {'name': 'Total brain radiotherapy', 'type': 'RADIATION', 'description': '30 Gy in 10 daily fractions from Monday to Friday', 'armGroupLabels': ['Chloroquine, radiosensitizer', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cancerologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Oscar Arrieta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cancerologia, Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cancerologia de Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oscar Gerardo Arrieta RodrÃguez', 'investigatorAffiliation': 'Instituto Nacional de Cancerologia de Mexico'}}}}