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)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05224934


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