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NCT Number: NCT05224934

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Nian-Zeng Xing, M.D

PRINCIPAL_INVESTIGATOR

Ning-Ning Lu, M.D.

PRINCIPAL_INVESTIGATOR

Ningning Lu, Doctor

CONTACT

[email protected]

+86 01087787630

Shu-Lian Wang, M.D

PRINCIPAL_INVESTIGATOR

Shu-Lian Wang, M.D.

CONTACT

[email protected]

+86 01087788280

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultra-hypofractionated radiotherapy

Radiation

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

Primary outcomes

  1. Peri-operative complications

    Time frame: From surgery date up to 7 days later

    The proportion of patients who suffer from

Study contacts

Contact information is provided by the study sponsor or research team.

Ning-Ning Lu

CONTACT

[email protected]

+868611804268

Shu-Lian Wang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma

Acronym: FUSION-01

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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