Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)
Recruiting · NCT06427460 · Interventional (participants receive a specific treatment) · Lead sponsor: Changhai Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Central-boost ablative dose delivered by stereotactic body radiation therapy
What this trial is about
In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Aged 18-75 years.
- Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
- Oligometastasis in the case of metastatic tumor
- the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
- ECOG of 0 to 1 point
- No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)
Exclusion criteria
- History of radiotherapy for the lesion
- History of tumor within 5 years
- ECOG ≥2 points
- Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
- Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
- Infections required antibiotics
- Heart or respiratory insufficiency
- Pregnant or breastfeeding women
Where it is running
1 location listed.
- Huojun Zhang - Shanghai, Shanghai Municipality, China