Clinical trial · Interventional
Preoperative Hypofractionated RT + Immunotherapy & Surgery for Retroperitoneal Sarcoma (FUSION-02)
Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)
NCT07396116CI-TRIAL-00103138FUSION-02not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy combined with immunotherapy followed by surgery for retroperitoneal sarcoma
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Retroperitoneal Sarcoma | Retroperitoneal Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma (STS) | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
| Ultra-hypofractionated Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultra-hypofractionated radiotherapy combined with immunotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiotherapy Combined with Immunotherapy
- description
- Patients receive hypofractionated radiotherapy with 43.5Gy in 15 fractions, combined with immunotherapy, followed by surgery done at 6-10 weeks post-radiotherapy (RT).
- interventionNames
- Radiation: ultra-hypofractionated radiotherapy combined with immunotherapy
Primary outcomes (1)
- measure
- Peri-operative complications
- timeFrame
- From surgery date up to 7 days later
- description
- The proportion of patients who suffer from
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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. * Distant Metastasis: Presence of distant metastasis (M1) confirmed by comprehensive imaging/examination within 4 weeks prior to enrollment. * Contraindications to Surgery/Protocol: Presence of other severe medical comorbidities that contraindicate surgery or preclude participation in the study. * Planned Neoadjuvant Chemotherapy: Patients scheduled to receive (concurrent) neoadjuvant chemotherapy. * Recent Systemic Therapy: Receipt of chemotherapy or other systemic treatments within 4 weeks prior to enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.