Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 5:11 PM
Study NCT ID:
NCT05442333
Status:
UNKNOWN
Last Update Posted:
2023-05-17
First Post:
2022-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2022-04-15', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound and local complications', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resectable Soft Tissue Sarcoma', 'Extremities', 'Radiotherapy Wound Complications']}, 'descriptionModule': {'briefSummary': 'Extremity soft tissue sarcomas (ESTS)s are rare mesenchymal cancers that considered a challenge for orthopaedic surgeons. Soft tissue sarcomas (STS) comprise less than 1% of malignant cancers, commonly occur in the proximal extremities and trunk. Limb-sparing surgery mostly are targeted in most of the patients, so adjuvant or neoadjuvant radiotherapy is usually added. Preoperative radiotherapy (neoadjuvant) or postoperative radiotherapy (adjuvant) offers local control and survival rates, but the local complications are controversial. However, different retrospective studies had shown that preoperative radiotherapy cause higher wound complication rate, while both preoperative and postoperative radiotherapy had the same results regarding local recurrence', 'detailedDescription': 'Study Tools :The patients will be managed as follows:\n\nPrimary (Preoperative) Diagnosis and Evaluation\n\nClinical Evaluation. History. General examination. Local examination.\n\nRadiological Evaluation:\n\nPlain X-ray for the affected limb to determine presence of any bone affection or invasion.\n\nPreoperative MRI scan to determine the extent of soft tissue, bone and neurovascular bundle invasion.\n\nPreoperative bone scan to determine skeletal metastatic load.\n\nPerioperative protocol:\n\nPreoperative radiotherapy 3-6 weeks before surgical excision. Postoperative radiotherapy 3- 6 weeks or more after surgical excision Tissue diagnosis will be obtained.\n\nOperative management:\n\nSurgical excision of whole tumour with wide safety margin.\n\nData collection:\n\nPatient demographics (age, sex). Activity level Primary sarcoma type Patient comorbidities Timing of Preoperative radiotherapy if present. Timing of Postoperative radiotherapy if present. Time from diagnosis to surgery. recurrence Operative time (minutes) measured from skin incision to wound closure. Follow up regarding wound complications, local recurrence or infection. local recurrence will be followed up till the end of the study\n\nFollow up strategy:\n\nThe patients with preoperative radiotherapy:\n\nwill be assessed 2 weeks postoperative regarding wound signs of infection (redness, hotness or discharge).\n\n1 month postoperatively for wound complete closure and exclude signs of infection.\n\n3 months postoperatively for wound dehiscence, swelling or local recurrence. 6 months postoperatively for local recurrence, pathological fractures or joint stiffness\n\nThe patients with postoperative radiotherapy:\n\nwill be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).\n\n6 weeks post radiation for wound dehiscence 3 months post radiation for local swelling or recurrence 6 months post radiation for local recurrence, joint stiffness or pathological fractures.\n\nStatistical Analysis: Statistical package for social science (SPSS 15.0.1 for windows ; 〖SPSS Inc,Chicago,IL,2001). Data will be presented as Mean and Standard deviation ( +/-SD) for quantitative parametric data , and Median and Interquartile range for quantitative non parametric data. Frequency and percentage will be used for presenting qualitative data. Suitable analysis will be done according to the type of data obtained. P\\<0.05 will be considered significant.\n\nStatistical Package: data entry and statistical analysis of the collected data will be performed using reliable software program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: both sexes.\n* Lesion: any soft tissue sarcoma in upper or lower limbs (synovial sarcoma, liposarcoma, fibrosarcoma and others)\n* age more than 16 years old\n\nExclusion Criteria:\n\n* Irresectable ESTS\n* Round cell ESTS\n* recurrent ESTS\n* patients who received local irradiation due to other causes'}, 'identificationModule': {'nctId': 'NCT05442333', 'briefTitle': 'Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications', 'orgStudyIdInfo': {'id': 'ziad khaled'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'preoperative radiotherapy', 'description': 'The patients which will receive preoperative radiotherapy', 'interventionNames': ['Procedure: surgical resection with safety margin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'postoperative radiotherapy', 'description': 'The patients which will receive postoperative radiotherapy', 'interventionNames': ['Procedure: surgical resection with safety margin']}], 'interventions': [{'name': 'surgical resection with safety margin', 'type': 'PROCEDURE', 'otherNames': ['pre operative radiotherapy', 'post operative radiotherapy'], 'description': '• The patients with preoperative radiotherapy:\n\n1. will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).\n2. 6 weeks post radiation for wound dehiscence\n3. 3 months post radiation for local swelling or recurrence\n4. 6 months post radiation for local recurrence, joint stiffness or pathological fractures.\n\nThe patients with postoperative radiotherapy:\n\n1. will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).\n2. 6 weeks post radiation for wound dehiscence\n3. 3 months post radiation for local swelling or recurrence\n4. 6 months post radiation for local recurrence, joint stiffness or pathological fractures.', 'armGroupLabels': ['postoperative radiotherapy', 'preoperative radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '12 months', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'orthopedic oncology department assistant lecturer', 'investigatorFullName': 'Ziad Khaled Abdullah Abdul Qader', 'investigatorAffiliation': 'Ain Shams University'}}}}