Preoperative Ultra-hypofractionated Radiotherapy Followed... | NCT05224934

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

NCT05224934

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Recruiting

Last Update Posted

Dec 11, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

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

Interventions

ultra-hypofractionated radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Jan 25, 2022

First Posted Date

Feb 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ultra-hypofractionated radiotherapy	Radiation	stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively	Ultra-hypofractionated radiotherapy

Measure	Description	Time Frame
Peri-operative complications	The proportion of patients who suffer from	From surgery date up to 7 days later

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ning-Ning Lu	Contact	+868611804268		Ning-Ning.Lu@hotmail.com
Shu-Lian Wang	Contact			wsl20040118@yahoo.com

Overall Officials

Name	Affiliation	Role
Ning-Ning Lu	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Recruiting	Beijing	Beijing Municipality	100021	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012509	Sarcoma
D011832	Radiation Injuries

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014947	Wounds and Injuries