Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

Qualifiers

Diagnosis & Indication: Primary or recurrent abdominopelvic soft tissue sarcoma. Patients are deemed to have a high probability of R1/R2 resection with upfront surgery and are confirmed to require radiotherapy following Multidisciplinary Team (MDT) discussion.

Target Volume: In cases of multifocal disease, all lesions must be safely encompassable within a single radiotherapy target volume.

Age: Age ≥ 18 years.

Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0-2; American Society of Anesthesiologists (ASA) score ≤ 2; patients must be expected to tolerate surgery and radiotherapy.

Disqualifiers

Significant Comorbidities: Patients with the following concurrent conditions: active hemorrhage, ulceration, intestinal perforation, intestinal obstruction, uncontrolled hypertension, cardiac insufficiency (NYHA Class III-IV), severe hepatic or renal dysfunction (Grade 4), mesenteric ischemia, or severe inflammatory bowel disease (IBD).

Excluded Histologies: Other pathological types, including Gastrointestinal Stromal Tumor (GIST), sarcomatoid carcinoma, sarcomas primarily treated with chemotherapy (e.g., rhabdomyosarcoma and PNET), desmoid fibromatosis, and benign tumors.

Unresectability: Tumor invasion into critical structures such as the liver, pancreatic head, or abdominal aorta, rendering the tumor deemed unresectable.

Prior Radiotherapy: History of prior radiotherapy to the same anatomical region.

Trial design

Treatments tested in this trial

  • ultra-hypofractionated radiotherapy combined with immunotherapy

Treatment groups

28 Participants
are divided into 1 treatment group