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Recruiting NCT05224934

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

No phase Interventional Soft Tissue Sarcoma Retroperitoneal Sarcoma Radiotherapy Side Effect Ultra-hypofractionated Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultra-hypofractionated radiotherapy.
Who it may be relevant to
Registry conditions: Soft Tissue Sarcoma, Retroperitoneal Sarcoma, Radiotherapy Side Effect, Ultra-hypofractionated Radiotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Radiation ultra-hypofractionated radiotherapy
    stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively

Primary outcome measures

  • Peri-operative complications [Time frame: From surgery date up to 7 days later]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT05224934 · NCC-007744

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗