Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT05224934
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-operative complications', 'timeFrame': 'From surgery date up to 7 days later', 'description': 'The proportion of patients who suffer from'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stereotactic ablative radiotherapy', 'hypofractionated radiotherapy', 'retroperitoneal sarcoma', 'soft tissue sarcoma', 'peri-operative complications'], 'conditions': ['Soft Tissue Sarcoma', 'Retroperitoneal Sarcoma', 'Radiotherapy Side Effect', 'Ultra-hypofractionated Radiotherapy', 'Stereotactic Ablative Radiotherapy']}, 'descriptionModule': {'briefSummary': 'To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis\n* Sarcoma not originated from bone structure, abdominal or gynecological viscera\n* All disease can be included safely within one radiotherapy field\n* Absence of extension through the sciatic notch or across the diaphragm\n* Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma\n* ECOG performance status 0 to 2\n* American Society of Anesthesiologist (ASA) score ≤2\n* Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan\n* Normal bone marrow and hepatic function.\n* Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age\n* expected life expectancy longer than 5 years\n* Written consent form was given prior to treatment\n* Can safely be treated by radiotherapy and surgery\n\nExclusion Criteria:\n\n* metastatic disease\n* Tumor was previously treated by radiotherapy\n* Involvement of liver, pancreatic head or duodenum'}, 'identificationModule': {'nctId': 'NCT05224934', 'acronym': 'FUSION-01', 'briefTitle': 'Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma', 'orgStudyIdInfo': {'id': 'NCC-007744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultra-hypofractionated radiotherapy', 'description': 'Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT', 'interventionNames': ['Radiation: ultra-hypofractionated radiotherapy']}], 'interventions': [{'name': 'ultra-hypofractionated radiotherapy', 'type': 'RADIATION', 'description': 'stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively', 'armGroupLabels': ['Ultra-hypofractionated radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ningning Lu, Doctor', 'role': 'CONTACT', 'email': 'Ning-Ning.Lu@hotmail.com', 'phone': '+86 01087787630'}, {'name': 'Shu-Lian Wang, M.D.', 'role': 'CONTACT', 'email': 'wsl20040118@yahoo.com', 'phone': '+86 01087788280'}, {'name': 'Nian-Zeng Xing, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shu-Lian Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ning-Ning Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ning-Ning Lu', 'role': 'CONTACT', 'email': 'Ning-Ning.Lu@hotmail.com', 'phone': '+868611804268'}, {'name': 'Shu-Lian Wang', 'role': 'CONTACT', 'email': 'wsl20040118@yahoo.com'}], 'overallOfficials': [{'name': 'Ning-Ning Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'NINGNING LU', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}