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

NCT06427460 | Recruiting Phase 2 DMC

• 1 other identifier: Changhai Hospital NMU
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; stereotactic body radiation therapy; inner gross tumor volume; central boost; ablative radiation dose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival will be determined.

  2 years

• Progression free survival will be determined.

  2 years

• Treatment related adverse events

  2 years

Study Arms (1)

stereotactic body radiation therapy

EXPERIMENTAL

Central-boost ablative doses delivered by SBRT.

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

Interventions

Central-boost ablative dose delivered by stereotactic body radiation therapy 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.

stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Huojun Zhang

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Huojun Zhang, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofei Zhu

CONTACT

86-021-31162222; zhuxiaofei_zxf@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 12, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)