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Not yet recruiting NCT07396116

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

No phase Interventional Soft Tissue Sarcoma (STS) Retroperitoneal Sarcoma Immunotherapy Radiotherapy Side Effect

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 combined with immunotherapy.
Who it may be relevant to
Registry conditions: Soft Tissue Sarcoma (STS), Retroperitoneal Sarcoma, Immunotherapy, Radiotherapy Side Effect. 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

Preoperative Hypofractionated Radiotherapy Combined With Immunotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-02)

Overview

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

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

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: NCT07396116 · NCC FUSION-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗