Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02) (NCT07396116) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)
China28 participantsStarted 2026-02-12
Plain-language summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Pathology: Histologically confirmed soft tissue sarcoma.
* Measurability: Presence of evaluable lesions.
* Life Expectancy: Life expectancy \> 5 years.
* Hematological \& Hepatic Function: Adequate organ function
* Renal Function: Adequate renal function defined as Glomerular Filtration Rate (GFR) ≥ 50 ml/min (calculated by Cockcroft-Gault formula), and split renal function imaging confirms function in the contralateral kidney.
* Contraception: Female patients of childbearing potential, or male patients with female partners of childbearing potential, must agree to use effective contraception during the entire treatment period and for 6 months after the last dose.
* Consent: Signed informed consent form.
* Follow-up: Capable of complying with follow-up requirements.
Exclusion Criteria:
* Significant Comorbidities: Patients with the foll…
What they're measuring
1
Peri-operative complications
Timeframe: From surgery date up to 7 days later
Trial details
NCT IDNCT07396116
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences