Soft Tissue SarcomaFUSION-01NCT05224934
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
A study testing ultra-hypofractionated radiotherapy in people with Soft Tissue Sarcoma and Retroperitoneal Sarcoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Retroperitoneal Sarcoma, Radiotherapy Side Effect
- What is being tested?
- ultra-hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- metastatic disease
- Tumor was previously treated by radiotherapy
- Involvement of liver, pancreatic head or duodenum
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shu-Lian Wang contact
China1 site, 1 recruiting
- Recruiting
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ningning Lu, Doctor, +86 01087787630, Ning-Ning.Lu@hotmail.com
Shu-Lian Wang, M.D., +86 01087788280, wsl20040118@yahoo.com
About this study
Official title: Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
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
- Being tested
- ultra-hypofractionated radiotherapy
- Keywords
- stereotactic ablative radiotherapy, hypofractionated radiotherapy, retroperitoneal sarcoma, soft tissue sarcoma, peri-operative complications
- Medical subject headings
- Sarcoma, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-hypofractionated radiotherapyRadiation
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: ultra-hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative complications
The proportion of patients who suffer from
Measured: From surgery date up to 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ning-Ning Lu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224934
- Sponsor's protocol ID
- NCC-007744
- Acronym
- FUSION-01
- Status last verified
- Dec 2025
- First submitted
- 25 Jan 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided