Central-boost ablative dose delivered by stereotactic body radiation therapy
Central-boost ablative dose delivered by stereotactic body radiation therapy: An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
One-year local control will be determined. — 1 year The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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