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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427460
• Other study ID #: Changhai Hospital NMU
• Status: Recruiting
• Phase: Phase 2
• Start date: May 12, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Changhai Hospital
• Contact: Xiaofei Zhu
• Phone: 86-021-31162222
• Email: zhuxiaofei_zxf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Huojun Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year local control will be determined.	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.	1 year
Secondary	Overall survival will be determined.	The time from the enrollment to death.	2 years
Secondary	Progression free survival will be determined.	The time from the enrollment to documentation of any clinical or radiological disease progression or death, whichever occurred first. 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.	2 years
Secondary	Treatment related adverse events	Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.	2 years