RecruitingNot ApplicableNCT05224934
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment
50 participants
Start Date
Jan 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Eligibility
Min Age: 18 Years
Inclusion Criteria13
- Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis
- 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 Criteria3
- metastatic disease
- Tumor was previously treated by radiotherapy
- Involvement of liver, pancreatic head or duodenum
Interventions
RADIATIONultra-hypofractionated radiotherapy
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05224934
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