Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT05561634
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D019370', 'term': 'Observation'}, {'id': 'C538724', 'term': 'HhAntag691'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-29', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a local relapse at 2 years in both groups.', 'timeFrame': 'At 2 years'}], 'secondaryOutcomes': [{'measure': 'Occurrence of local relapse at 1 and 3 years.', 'timeFrame': 'at 1 year and at 3 years'}, {'measure': 'Occurrence of adverse effects in the radiotherapy group.', 'timeFrame': 'at 1 year, at 2 years and at 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally advanced basal cell carcinoma', 'Sonic Hedgehog inhibitors', 'Consideration radiotherapy'], 'conditions': ['Basal Cell Carcinoma', 'Radiotherapy; Complications']}, 'descriptionModule': {'briefSummary': 'Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over 18 years\n* Locally advanced non-recurrent BCC in complete response after first course of SHHi\n* Complete response has to be confirmed histologically\n* Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor\n\nExclusion Criteria:\n\n* Patients with distant metastasis\n* Patients with Gorlin's syndrome\n* Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields\n* Pregnant women\n* Life expectancy less than 1 year\n* Inability to receive informed consent\n* Inability to participate in the entire study\n* Lack of social security coverage\n* Refusal to sign consent"}, 'identificationModule': {'nctId': 'NCT05561634', 'acronym': 'RADIOSONIC', 'briefTitle': 'Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study', 'orgStudyIdInfo': {'id': '2021_0710'}, 'secondaryIdInfos': [{'id': '2022-A01424-39', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'SHHI then follow-up', 'interventionNames': ['Radiation: Radiotherapy', 'Other: Observation']}, {'type': 'EXPERIMENTAL', 'label': 'SHHI then radiotherapy', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Vismodegib']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Irradiation of the tumoral bed.', 'armGroupLabels': ['SHHI then follow-up', 'SHHI then radiotherapy']}, {'name': 'Observation', 'type': 'OTHER', 'description': 'Patients will be followed up in consultation every 3 months.', 'armGroupLabels': ['SHHI then follow-up']}, {'name': 'Vismodegib', 'type': 'DRUG', 'description': 'Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,', 'armGroupLabels': ['SHHI then radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent MORTIER, Pr', 'role': 'CONTACT', 'email': 'laurent.mortier@chu-lille.fr', 'phone': '0320444237'}], 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Laurent Mortier, MD,PhD', 'role': 'CONTACT', 'email': 'laurent.mortier@chru-lille.fr', 'phone': '0320445962'}], 'overallOfficials': [{'name': 'Laurent Mortier, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}