Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 7:00 PM
Study NCT ID:
NCT07202260
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pragmatic Analysis of Complex Radiotherapy Cases In Cancer of the Lung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient reported quality of life', 'timeFrame': '2 years', 'description': '\\- Patient reported quality of life (QOL) information from electronic patient reported outcome measure (ePROM) questionnaires.'}, {'measure': 'Survival', 'timeFrame': '2 years', 'description': '\\- Progression-free survival and overall survival.'}], 'primaryOutcomes': [{'measure': 'Acute and late toxicity', 'timeFrame': '2 years', 'description': '\\- Acute (\\<90 days post radiotherapy) and late (\\> 90 days post radiotherapy) toxicity according to common terminology criteria for adverse events (CTCAE) V5.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiotherapy', 'interstitial lung disease', 'vascular invasion', 're-irradiation', 'rare histology'], 'conditions': ['Lung Cancer (NSCLC)', 'Lung Cancer (SCLC)']}, 'descriptionModule': {'briefSummary': 'This study focuses on improving care for people with lung cancer who face unusual or complex treatment situations.', 'detailedDescription': 'By studying detailed patient data, researchers aim to find the best ways to treat these patients while reducing short- and long-term side effects. The findings will help refine radiotherapy treatments, ensuring they are as safe and effective as possible. Additionally, the results will provide doctors with better information to help patients understand the potential risks and benefits of their treatment options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age, with stage I, II or III lung cancer undergoing curative-intent radiotherapy at the Christie Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Complex patients with lung cancer undergoing radiotherapy in one of the following groups;\n\n* Rare histology\n* Disease invading vascular structures\n* Co-existing interstitial lung disease (ILD)\n* Radical re-irradiation\n* Oligopersistent/oligoprogressive disease on immunotherapy or targeted therapies.\n\nExclusion Criteria:\n\n* Include patients with stage IV disease who are receiving non-curative intent radiotherapy\n* There are no exclusion criteria relating to upper age limit or comorbidities.'}, 'identificationModule': {'nctId': 'NCT07202260', 'acronym': 'PRACTICAL', 'briefTitle': 'Pragmatic Analysis of Complex Radiotherapy Cases In Cancer of the Lung', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'Pragmatic Analysis of Complex Radiotherapy Cases In Cancer of the Lung (The PRACTICAL Study)', 'orgStudyIdInfo': {'id': 'CFTSP 230'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with co-existing interstitial lung disease'}, {'label': 'Patients who undergo radiotherapy twice to the same area (reirradiation).'}, {'label': 'Patients with the less common or rare types of lung cancer'}, {'label': 'Patients with cancer invading large blood vessels.'}, {'label': 'Patients with oligopersistent/oligoprogressive disease on immunotherapy or targeted therapies.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 1BX', 'city': 'Withington', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 52.71667, 'lon': -2.6}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}