Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Ultra-hypofractionated Radiotherapy; Radiotherapy Side Effect; Retroperitoneal Sarcoma; Soft Tissue Sarcoma; Stereotactic Ablative Radiotherapy

Treatments: Radiation: ultra-hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05224934

NCC-007744

Details and patient eligibility

About

To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ultra-hypofractionated radiotherapy

Experimental group

Description:

Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT

Treatment:

Radiation: ultra-hypofractionated radiotherapy