Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-02-03 @ 1:54 PM
Study NCT ID:
NCT03175861
Status:
UNKNOWN
Last Update Posted:
2018-10-19
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinetics of PET-CT parameters : standardized uptake value (SUV) max', 'timeFrame': '2 years', 'description': 'SUV max will be measured before and after stereotactic irradiation.'}, {'measure': 'Tumor metabolic response', 'timeFrame': '2 years', 'description': 'Tumor metabolic response, as assessed on 18F-FDG PET-CT at 6 months of end of radiotherapy'}, {'measure': 'Local control', 'timeFrame': '2 years', 'description': 'Local control defined by the absence of progression in the irradiated area'}, {'measure': 'Kinetics of PET-CT parameters : metabolic tumor volume', 'timeFrame': '2 years', 'description': 'Metabolic tumor volume (MTV) will be measured before and after stereotactic irradiation.'}, {'measure': 'Kinetics of PET-CT parameters : texture parameters :quantitative extraction of images by specific software', 'timeFrame': '2 years', 'description': 'The first-order form parameters and statistical parameters, the second order (based on the matrix of co-occurrence of the grey levels and the matrix of differences of grey levels) and of the third order (based on the matrices of alignment of the grey levels and the matrices of sizes of zones) will be studied.'}], 'secondaryOutcomes': [{'measure': 'Kinetics of serum markers', 'timeFrame': '2 years', 'description': 'The kinectic will be measured'}, {'measure': 'Predictive power of serum markers for tumor response and local control', 'timeFrame': '2 years', 'description': 'This predictive power will be measured'}, {'measure': 'Predictive power of metabolic imaging parameters for tumor response and local control Predictive power of metabolic imaging parameters for tumor response and local control', 'timeFrame': '2 years', 'description': 'This predictive power will be measured'}, {'measure': 'Correlation between these parameters', 'timeFrame': '2 years', 'description': 'The correlation will be measured'}, {'measure': 'Survival in disease', 'timeFrame': '2 years', 'description': 'The survival in desease will be observed'}, {'measure': 'Survival without metastasis at a distance', 'timeFrame': '2 years', 'description': 'The survival without metastasis will be observed'}, {'measure': 'Radiation-induced toxicity', 'timeFrame': '2 years', 'description': 'The radiation-induced toxicity will be observed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': 'Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control', 'detailedDescription': 'The identification of robust prognostic and predictive markers could allow the individualization of pulmonary stereotactic radiotherapy treatments and the selection of patients at high risk of relapse, who could then benefit from a dose escalation in order to increase the chances of local control .\n\nBeyond the pulmonary RTS (Radiotherapy in stereotactic condition), this study will aim to generate one or more models of multi-scale response to hypofractionated irradiation from biomarkers (biological or images) extracted from preclinical or clinical literature data and to allow simulations of Various modified fractionation irradiation schemes, potentially leading to new regimens that reduce side effects and increase therapeutic efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All major patients requiring stereotactic radiotherapy for non-small cell bronchopulmonary carcinoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years\n* Performance Index WHO (World Health Organization) ≤ 2\n* Bronchopulmonary carcinoma not in small cells proved histologically or cytologically (epidermoid, adenocarcinoma, or large cell carcinoma).\n* Tumor classified T1 - T2 (Tumor=1-2) N0 (Node=0) M0 (Metastasis=0) and diameter ≤ 5 cm or Tumor classified T3 (≤5cm) N0M0 of the chest wall\n* Tumor located more than 2 cm from the trachea and bronchus stem and more than 1.5 cm from the organs at risk\n* Medically inoperable or refusing surgery\n* Indication of stereotactic radiotherapy validated in multidisciplinary consultation meeting\n* Formulation of consent\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* History of pulmonary irradiation\n* Pulmonary surgery of the tumor\n* Different histology of non-small cell carcinoma\n* Patient with a T2 or T3\\> 5 cm tumor or patients with a T3 tumor invading a structure other than the chest wall\n* Patient with a tumor within 2 cm of the trachea and bronchus stem and within 1.5 cm of the organs at risk in the proximal area of the no fly zone (defined as a volume Located 2 cm in all directions of the proximal bronchial tree - Pulmonary metastases\n* Declared pregnancy, breast-feeding\n* Refusal to use effective contraception\n* Against indication to the realization of the PET to the 18FDG (18-fluorodeoxyglucose)(uncontrolled diabetes)\n* Refusal or inability to consent to participate in the study.\n* Estimated life expectancy \\<2 months in the absence of treatment\n* Other invasive tumors diagnosed in the previous 2 years, with the exception of non-melanocytic cutaneous carcinomas.'}, 'identificationModule': {'nctId': 'NCT03175861', 'acronym': 'MUMOFRAT', 'briefTitle': 'Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Multiscale Modeling / Simulation of the Response to Pulmonary Stereotactic Hypofractionated Irradiation', 'orgStudyIdInfo': {'id': 'MUMOFRAT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stereotactic radiotherapy', 'type': 'OTHER', 'description': 'The patient will have an initial pre-therapeutic assessment in the 8 weeks before the start of radiotherapy Then, radiation therapy planning with 3 free breathing 4D (4 dimensions) scanners performed over 8 days without injection of iodinated contrast agent.\n\nThen the patient will receive his treatment by conventional stereotactic radiotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ulrike Schick, Doctor', 'role': 'CONTACT', 'email': 'ulrike.schick@chu-brest.fr', 'phone': '0298223398', 'phoneExt': '+33'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '35042', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Enrique Chajon', 'role': 'CONTACT', 'email': 'e.chajon@rennes.unicancer.fr', 'phone': '+33(0)2 99 25 30 92'}], 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44805', 'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc André Mahé', 'role': 'CONTACT', 'email': 'marc-andre.mahe@ico.unicancer.fr', 'phone': '+33(0)2 40 67 99 00'}], 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '37000', 'city': 'Tours', 'status': 'COMPLETED', 'country': 'France', 'facility': "Clinique d'Oncologie et Radiothérapie", 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Ulrike Schick, Doctor', 'role': 'CONTACT', 'email': 'ulrike.schick@chu-brest.fr', 'phone': '0298223398', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Ulrike Schick, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}