NCT06427460

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

Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	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.

Timeline

• Start date: 2024-05-12
• Primary completion: 2025-06-30
• Completion: 2026-12-31
• First posted: 2024-05-23
• Last updated: 2024-05-23

Locations

1 site across 1 country: China