Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-09 @ 7:26 PM
Study NCT ID:
NCT02421718
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2015-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'Within 1 week before or after last day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at 3 months after first day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at 6 months after first day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at one year after first day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at 2 years after first day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at 3 years after first day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at 4 years after first day of radiation therapy'}, {'measure': 'Patient-rated symptoms and Quality-of-Life', 'timeFrame': 'at 5 years after first day of radiation therapy'}], 'primaryOutcomes': [{'measure': 'Acute toxicity', 'timeFrame': 'Highest during and within 2 weeks after last day of radiation therapy', 'description': 'esophagitis (Common Terminology Criteria for Adverse Events, version 4.0)'}, {'measure': 'Late toxicity', 'timeFrame': 'Highest within one year after last day of radiation therapy', 'description': 'esophagitis (Common Terminology Criteria for Adverse Events, version 4.0); pneumonitis (Common Terminology Criteria for Adverse Events, version 4.0)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'at 1 year after first day of radiation therapy'}, {'measure': 'Overall survival', 'timeFrame': 'at 2 years after first day of radiation therapy'}, {'measure': 'Overall survival', 'timeFrame': 'at 3 years after first day of radiation therapy'}, {'measure': 'Overall survival', 'timeFrame': 'at 4 years after first day of radiation therapy'}, {'measure': 'Overall survival', 'timeFrame': 'at 5 years after first day of radiation therapy'}, {'measure': 'Loco-regional tumor control', 'timeFrame': 'at 1 year after first day of radiation therapy'}, {'measure': 'Loco-regional tumor control', 'timeFrame': 'at 2 years after first day of radiation therapy'}, {'measure': 'Loco-regional tumor control', 'timeFrame': 'at 3 years after first day of radiation therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute toxicity', 'Late toxicity', 'Prediction models'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Motive:\n\nIn order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from lung cancer patients.\n\nGoal:\n\nTo set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.\n\nA standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer - Limited Disease (SCLC-LD) or thymoma or lungmetastases (treated with stereotactic radiotherapy), receiving radiotherapy dose \\> 40 Gy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with NSCLC or SCLC-LD or thymoma or lung metastases (treated with stereotactic radiotherapy)\n* Patients receiving radiotherapy dose \\> 40 Gy\n\nExclusion Criteria:\n\n* Failure to comply with any of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02421718', 'briefTitle': 'Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Standard Follow-up Program (SFP) for Lung Cancer Patients Treated With Radiotherapy or Chemoradiation', 'orgStudyIdInfo': {'id': 'SFP LUNG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Chemoradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Robin Wijsman, MD', 'role': 'CONTACT', 'email': 'r.wijsman@umcg.nl', 'phone': '+31503615532'}, {'name': 'Robin Wijsman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Robin Wijsman, MD PhD', 'role': 'CONTACT', 'email': 'r.wijsman@umcg.nl', 'phone': '+31503615532'}], 'overallOfficials': [{'name': 'Robin Wijsman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}