Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-03-12 @ 3:24 AM
Study NCT ID:
NCT02785692
Status:
TERMINATED
Last Update Posted:
2018-10-02
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal Investigator has left the Institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-30', 'studyFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major and minor wound healing complications', 'timeFrame': 'through study completion, minimum 6 weeks post surgery'}], 'secondaryOutcomes': [{'measure': 'Local and metastatic disease control based on imaging such as CT scans and MRI', 'timeFrame': 'maximum 10 years post surgery'}, {'measure': 'Overall survival at the latest point of follow- up', 'timeFrame': 'maximum 10 years post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['soft tissue sarcoma', 'IMRT and sarcoma', 'preoperative highly conformal radiation therapy', 'soft tissue sarcoma and wound healing', 'postoperative complications', 'treatment tolerance of soft tissue IMRT'], 'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': 'Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. The literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. The Canadian prospective randomized NCIC SR2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment concept and the results shall now be analysed and published. The approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.', 'detailedDescription': 'Introduction: The Canadian prospective randomized NCIC SR2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. Similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-IMRT) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, \\[95% CI 5-30\\], p=0ยท01).\n\nThe investigators assessed a single center preoperative IMRT (or IMRT-equivalent highly conformal three dimensional conventional RT (3DcRT)) cohort with respect to the wound complication rate (WCR). The hypothesis was that a lower WCR rate was achieved in the era of IMRT as compared to the non-IMRT era when the Canadian Trial was conducted.\n\nMethods: 67 consecutive patients irradiated with 50Gy in 25 fractions between 3/2008-3/2016 with preoperative IMRT (n=48, 72%) or highly conformal IMRT-equivalent 3DcRT dose distribution (n=19, 28%) were assessed. All patients were previously discussed at the weekly interdisciplinary sarcoma board of the Sarcoma Center Zurich.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '67 patients with histological proven malignant soft tissue sarcomas who underwent preoperative radiotherapy followed by surgical tumor resection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a malignant soft tissue tumour\n* Patients who underwent preoperative radiotherapy at the department of radiation oncology, University Hospital Zurich (USZ)\n* Surgical treatment at Balgrist University Hospital between 2007 and 2016\n\nExclusion Criteria:\n\n* Vulnerability\n* Previous chemotherapy\n* Previous radiotherapy on the affected site\n* Patient's wish"}, 'identificationModule': {'nctId': 'NCT02785692', 'briefTitle': 'Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications', 'orgStudyIdInfo': {'id': '2015-00100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined Radiation/ Surgery', 'description': 'All patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich', 'interventionNames': ['Radiation: Radiation']}], 'interventions': [{'name': 'Radiation', 'type': 'RADIATION', 'description': 'preoperative Radiotherapy/ IMRT', 'armGroupLabels': ['Combined Radiation/ Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Bruno Fuchs, Prof. MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Balgrist University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}