LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT.
James A Kavanaugh, Matthew B Spraker, Sai Duriseti...
https://pubmed.ncbi.nlm.nih.gov/34896459/Actively Recruiting
Led by Ji Yongling · Updated on 2026-08-04
12
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating a new treatment approach for patients with unresectable locally advanced non-small cell lung cancer NSCLC and large thoracic malignant solid tumors. This first prospective clinical study aims to assess the safety and effectiveness of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy. During the study, tumor tissue, blood, urine, and stool samples will be collected to explore markers that may predict how patients respond to treatment. Participants will receive an experimental treatment called Carbon Ion Lattice Radiation Therapy, which targets large thoracic tumors. This study involves a single treatment group where patients undergo this specialized radiation therapy designed for bulky solid tumors in the chest area. The treatment plan focuses on delivering precise doses of carbon ion radiation to the tumor while aiming to protect surrounding healthy tissue. Throughout the study, participants will be closely monitored for dose-limiting toxicities within 90 days after treatment. Researchers will evaluate safety and treatment effects through regular assessments. Participants must meet specific eligibility requirements, and all will provide informed consent. The study is expected to run until the end of 2028, with ongoing collection and analysis of biological samples to better understand treatment response.
CONDITIONS
Phase I Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Tumors
Y
Yongling Ji, MD
Q
Qingren Lin
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Ji Yongling
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by participant
Participants receive carbon ion lattice radiation therapy targeting large thoracic tumors.
Multiple visits depending on treatment plan
Duration - 90 days
Participants are monitored for dose-limiting toxicities and overall safety for 90 days after treatment.
Regular visits for safety assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Lead Sponsor