Recruiting NCT07744074
Phase I Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors.
- Who it may be relevant to
- Registry conditions: Carbon Ion Radiotheray. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm Phase I Clinical Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Malignant Tumors
Overview
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
Interventions
- Radiation Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors
Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors
Primary outcome measures
- Dose-Limiting Toxicities [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old;
- Pathologically confirmed thoracic solid malignant tumors;
- Local recurrence or failure of prior standard therapies (including surgery, radiotherapy, systemic therapy, etc.), deemed unsuitable for or lacking standard treatment options following Multidisciplinary Team (MDT) evaluation, and planned to receive heavy-ion radiotherapy；
- Maximum diameter of the target lesion ≥ 4.5 cm;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Life expectancy ≥ 6 months;
- Signed informed consent.
Exclusion criteria
- Tumors adjacent to critical organs at risk (OARs) where dose constraints cannot be met through plan optimization;
- Prior radiotherapy to the intended treatment area, where re-irradiation would fail to meet normal tissue dose constraints;
- Presence of recognized standard treatment options for which the patient is eligible (e.g., radical surgery, concurrent chemoradiotherapy, or standard systemic therapy);
- Primary hematologic malignancies;
- Uncontrolled severe comorbidities, including active infections, unstable cardiovascular or cerebrovascular diseases, and severe hepatic or renal insufficiency;
- Other diseases deemed by the investigator to compromise patient safety;
- Psychiatric disorders or cognitive impairment that would prevent cooperation with treatment;
- Pregnancy or lactation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Publications
- Tubin S, Popper HH, Brcic L. Novel stereotactic body radiation therapy (SBRT)-based partial tumor irradiation targeting hypoxic segment of bulky tumors (SBRT-PATHY): improvement of the radiotherapy outcome by exploiting the bystander and abscopal effects. Radiat Oncol. 2019 Jan 29;14(1):21. doi: 10.1186/s13014-019-1227-y. PMID 30696472
- Tubin S, Fossati P, Carlino A, Martino G, Gora J, Stock M, Hug E. Novel Carbon Ion and Proton Partial Irradiation of Recurrent Unresectable Bulky Tumors (Particle-PATHY): Early Indication of Effectiveness and Safety. Cancers (Basel). 2022 Apr 29;14(9):2232. doi: 10.3390/cancers14092232. PMID 35565361
- Duriseti S, Kavanaugh JA, Szymanski J, Huang Y, Basarabescu F, Chaudhuri A, Henke L, Samson P, Lin A, Robinson C, Spraker MB. LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4. PMID 34875286
- Kavanaugh JA, Spraker MB, Duriseti S, Basarabescu F, Price A, Goddu M, Knutson N, Prusator M, Robinson C, Mazur T. LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. Radiother Oncol. 2022 Feb;167:172-178. doi: 10.1016/j.radonc.2021.12.003. Epub 2021 Dec 9. PMID 34896459
- Li H, Mayr NA, Griffin RJ, Zhang H, Pokhrel D, Grams M, Penagaricano J, Chang S, Spraker MB, Kavanaugh J, Lin L, Sheikh K, Mossahebi S, Simone CB, Roberge D, Snider JW, Sabouri P, Molineu A, Xiao Y, Benedict SH. Overview and Recommendations for Prospective Multi-institutional Spatially Fractionated Radiation Therapy Clinical Trials. Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):737-749. doi: 10. PMID 38110104
Identifiers
NCT: NCT07744074 · IRB-2026-727(IIT)