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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

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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