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

NCT ID: NCT06427460

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-12
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stereotactic body radiation therapy

Central-boost ablative doses delivered by SBRT.

Group Type: EXPERIMENTAL

Central-boost ablative dose delivered by stereotactic body radiation therapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Huo Jun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huojun Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Huojun Zhang

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaofei Zhu

Role: CONTACT

zhuxiaofei_zxf@163.com

86-021-31162222

Facility Contacts

Xiaofei Zhu

Role: primary

zhuxiaofei_zxf@163.com

86-021-31162222

Other Identifiers

Changhai Hospital NMU

Identifier Type: -

Identifier Source: org_study_id