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

NCT05224934 | Recruiting

• 1 other identifier: NCC-007744
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

stereotactic ablative radiotherapy; hypofractionated radiotherapy; retroperitoneal sarcoma; soft tissue sarcoma; peri-operative complications

Outcome Measures

Primary Outcomes (1)

• Peri-operative complications

  The proportion of patients who suffer from

  From surgery date up to 7 days later

Study Arms (1)

Ultra-hypofractionated radiotherapy

EXPERIMENTAL

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

Radiation: ultra-hypofractionated radiotherapy

Interventions

ultra-hypofractionated radiotherapy RADIATION

stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively

Ultra-hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• metastatic disease
• Tumor was previously treated by radiotherapy
• Involvement of liver, pancreatic head or duodenum

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Sarcoma; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Wounds and Injuries

Study Officials

• Ning-Ning Lu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning-Ning Lu

CONTACT

+868611804268; Ning-Ning.Lu@hotmail.com

Shu-Lian Wang

CONTACT

wsl20040118@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

CN (1)