Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)

Trial Title: Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)

NCT ID: NCT06427460

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
pancreatic cancer
stereotactic body radiation therapy
inner gross tumor volume
central boost
ablative radiation dose

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Central-boost ablative dose delivered by stereotactic body radiation therapy
Description: 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.
Arm group label: stereotactic body radiation therapy

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.

Detailed description: Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk. In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Huojun Zhang

Address:
City: Shanghai
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Xiaofei Zhu

Phone: 86-021-31162222
Email: zhuxiaofei_zxf@163.com

Investigator:
Last name: Huojun Zhang, M.D.
Email: Principal Investigator

Start date: May 12, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Changhai Hospital
Agency class: Other

Source: Changhai Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06427460