Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
NCT ID: NCT05224934
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-01-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ultra-hypofractionated radiotherapy
Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT
ultra-hypofractionated radiotherapy
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
Interventions
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ultra-hypofractionated radiotherapy
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
Eligibility Criteria
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Inclusion Criteria
* Sarcoma not originated from bone structure, abdominal or gynecological viscera
* All disease can be included safely within one radiotherapy field
* Absence of extension through the sciatic notch or across the diaphragm
* 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
* ECOG performance status 0 to 2
* American Society of Anesthesiologist (ASA) score ≤2
* Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan
* Normal bone marrow and hepatic function.
* Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age
* expected life expectancy longer than 5 years
* Written consent form was given prior to treatment
* Can safely be treated by radiotherapy and surgery
Exclusion Criteria
* Tumor was previously treated by radiotherapy
* Involvement of liver, pancreatic head or duodenum
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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NINGNING LU
Principle Investigator
Principal Investigators
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Ning-Ning Lu
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC-007744
Identifier Type: -
Identifier Source: org_study_id
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