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

ConditionsSoft Tissue Sarcoma (STS)Retroperitoneal Sarcoma Immunotherapy Radiotherapy Side Effect Ultra-hypofractionated Radiotherapy

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

ultra-hypofractionated radiotherapy combined with immunotherapy
Radiation
ultra-hypo-fractionated radiotherapy with 43.5Gy in 15 fractions combined with immunotherapy, followed by surgery done at 6 to 10 weeks post-RT

Treatment groups

28 Participants

are divided into 1 treatment group

Group A: Hypofractionated Radiotherapy Combined with ImmunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Peri-operative complications

The proportion of patients who suffer from

Time frame

From surgery date up to 7 days later

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: