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Stereotactic Body Radiotherapy Based on MR-Linac for the Treatment of Inoperable Early-stage Non-small Cell Lung Cancer: A Single-arm, 2 Phase, Multicenter Clinical Trial

Stereotactic Body Radiotherapy Based on MR-Linac for the Treatment of Inoperable Early-stage Non-small Cell Lung Cancer: A Single-arm, 2 Phase, Multicenter Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059930
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

MRgSBRT group:SBRT based on MR-Linac

Sponsors

Cancer Hospital affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. NSCLC proved by pathology or cytology; For clinical early lung cancer that cannot be or refuses to accept pathological diagnosis, SBRT treatment can be considered if the following conditions are met: ? The clear imaging diagnosis of the focus is gradually increased during long-term follow-up (>2 years), or the density and proportion of ground-glass shadow are increased, or accompanied by vascular perforation and marginal burr-like changes and other malignant features; At least two kinds of imaging examinations (such as chest enhancement+1~3mm thin CT and whole body PET-CT) indicate malignancy; ? Determined by MDT discussion of lung cancer; ? The patients and their families fully informed consent. 2. The clinical stage is T1~T3N0M0 (according to the lung cancer stage IASLC, 2017, 8th edition); 3. Cannot operate or refuse to operate. Nonoperative indications: ? baseline FEV1 50 mm Hg); ? Exercise oxygen consumption < 50% predicted value; ? There are serious pulmonary hypertension, heart disease, cerebrovascular disease, peripheral vascular disease, etc; 4. Age: 18~75 years old, male and female; 5. The physical condition score (ECOG) of the Eastern Cancer Cooperation Group in the United States is 0-2 points, and the life expectancy is more than 6 months; 6. At least one measurable lesion; 7. No chemotherapy, targeted therapy and immunotherapy were used before enrollment; 8. No history of radiotherapy; 9. No serious allergic history; 10. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pathological or cytological diagnosis of small cell lung cancer; 2. There are contraindications for magnetic resonance examination; 3. History of malignant tumors in other parts; 4. According to the judgment of the researcher, there are serious complications that cannot be tolerated or completed radiotherapy; 5. There is acute inflammation requiring systematic treatment; 6. In the active period of infectious disease; 7. Pregnant women, lactating women, and patients with family planning during the study period; 8. Participate in other clinical trials at present or within 4 weeks before enrollment; 9. Unable to comply with the study protocol and follow-up procedures; 10. According to the judgment of the researcher, any other disease, metabolic disorder, physical examination results or laboratory examination abnormal results, and there is reason to suspect that the disease or disease may lead to contraindication of the use of the study treatment plan, or affect the reliability of the study results, or put the patient at high risk of treatment complications.

Design outcomes

Primary

MeasureTime frame
Progression-free survival, PFS;Disease control rate, DCR;

Secondary

MeasureTime frame
Objective response rate, ORR;Overall survival, OS;Complete toxicity;Grade>=3 toxicity;Grade>=3 treatment related toxicity;Features of MRI radiomics;

Countries

China

Contacts

Public ContactLigang Xing

Cancer Hospital affiliated to Shandong First Medical University

xinglg@medmail.com.cn+86 15553181309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026