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Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
RECRUITINGN/ASponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Actively Recruiting
PhaseN/A
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2022-01-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05224934
Summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * metastatic disease * Tumor was previously treated by radiotherapy * Involvement of liver, pancreatic head or duodenum
Conditions6
CancerRadiotherapy Side EffectRetroperitoneal SarcomaSoft Tissue SarcomaStereotactic Ablative RadiotherapyUltra-hypofractionated Radiotherapy
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Actively Recruiting
PhaseN/A
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2022-01-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05224934