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

Study Overview

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

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.

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.

Pancreatic Cancer

RADIATION: Central-boost ablative dose delivered by stereotactic body radiation therapy

Changhai Hospital NMU

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-19
First Submitted that Met QC Criteria 2024-05-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-23
First Posted (ACTUAL) 2024-05-23	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: stereotactic body radiation therapy Central-boost ablative doses delivered by SBRT.	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 30-40

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: stereotactic body radiation therapy

Central-boost ablative doses delivered by SBRT.

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 30-40

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Overall survival will be determined.	The time from the enrollment to death.	2 years
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xiaofei Zhu

Phone Number: 86-021-31162222

Email: zhuxiaofei_zxf@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Huojun Zhang, M.D., Changhai Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record