Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT04201002
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2019-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery Plus Intraoperative Radiotherapy as Treatment for Squamous Cell Carcinoma Over Pilonidal Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2019-12-13', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in recurrence rate', 'timeFrame': '1 year', 'description': 'Squamous cell carcinoma has a high recurrence rate, with surgery plus intraoperative radiotherapy we think it could decrease that recurrence rate.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilonidal sinus', 'Squamous cell carcinoma', 'Surgery', 'Intraoperative radiotherapy', 'Chemotherapy'], 'conditions': ['Squamous Cell Carcinoma', 'Pilonidal; Cyst, Malignant', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Background: Pilonidal sinus is a very common disease. Malignant transformation occurs in 0,1% of patients. The investigators present a case of squamous cell carcinoma arised from recurrent pilonidal disease, managed by multimodal treatment.\n\nCase presentation: The investigators present a 70-year-old man with chronic pilonidal sinus. Inflammation had worsened in previous months and exploration revealed a large ulcerative mass which biopsy showed a squamous cell carcinoma. CT scan and MRI imaging showed tumoral invasion of the coccyx and both gluteus major muscles. Neoadjuvant radiotherapy, chemotherapy as radiosensitizer and surgery with intraoperative radiotherapy was decided in the multidisciplinary tumor committee. Post neoadjuvant therapy MRI showed partial response with a decrease of the mass but persistence of the coccyx infiltration.\n\nSurgery consisted in en-bloc resection of the tumor with presacral tissues, coccyx and partial gluteal resection. Intraoperative radiotherapy was administered over the sacrum and in the bed of the coccyx resection. One week later, reconstructive surgery was practiced using a latissimus dorsi free flap, advancement of gluteal flaps and skin graft. Histological examination showed no residual tumor. The patient is currently asymptomatic and he has a satisfactory quality of life.\n\nConclusions: Although squamous cell carcinoma is rare, it must be suspected in patients with recurrent pilonidal disease. Diagnosis is done by histological examination of biopsies. This type of tumors have a high local recurrence rate. The investigators propose a multimodal treatment that includes neoadjuvant radiotherapy and chemotherapy as radiosensitizer and surgery plus intraoperative radiotherapy with the aim to decrease local recurrence rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We describe the diagnosis, treatment and follow-up of a patient with squamous cell carcinoma over pilonidal disease. The aim of the article is present the intraoperative radiotherapy plus en bloc surgery as a treatment in this cases with high recurrence rate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Squamous cell carcinoma over pilonidal disease\n\nExclusion Criteria:\n\n* Distant Metastases'}, 'identificationModule': {'nctId': 'NCT04201002', 'briefTitle': 'Surgery Plus Intraoperative Radiotherapy as Treatment for Squamous Cell Carcinoma Over Pilonidal Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Provincial de Castellon'}, 'officialTitle': 'Squamous Cell Carcinoma Over Pilonidal Disease. A New Therapeutic Approach.', 'orgStudyIdInfo': {'id': 'HPCastellon'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Resection plus intraoperative radiotherapy', 'type': 'PROCEDURE', 'description': 'En-bloc resection plus intraoperative radiotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12002', 'city': 'Castellon', 'state': 'Castellon', 'country': 'Spain', 'facility': 'Hospital Provincial Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'Castellon', 'country': 'Spain', 'facility': 'Hospital Provincial Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'overallOfficials': [{'name': 'Araceli Mayol Oltra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Provincial de Castellon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon', 'investigatorFullName': 'Araceli Mayol Oltra', 'investigatorAffiliation': 'Hospital Provincial de Castellon'}}}}