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A prospective study of carbon ion radiotherapy guided by 18F-FMISO hypoxic imaging in the treatment of locally advanced non-small cell lung cancer

A prospective study of carbon ion radiotherapy guided by 18F-FMISO hypoxic imaging in the treatment of locally advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036034
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

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

Case series:simultaneously integrated boost carbon ion radiation therapy

Sponsors

Shanghai Proton and Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Sign the informed consent; 2) Aged 18-80 years old; 3) Be able to comply with the plan; 4) Primary tumor should be confirmed by cytology or histology test; 5) Cytological or histopathological diagnosis of non-small cell lung cancer; T>=3cmN0-3M0 (UICC/AJCC 8th edition staging); 6) Patients who were medically inoperable (evaluated by thoracic surgeon), or patients who refuse surgery; 7) ECOG score 0-2; 8) The expected survival time is more than 6 months; 9) Adequate organ function to meet the basic requirements for the treatment.

Exclusion criteria

Exclusion criteria: 1. The patient's disease has not been confirmed by pathology; 2. Has other malignant tumors and has not been controlled; 3. The side effects of previous treatments have not recovered, such as systemic chemotherapy or targeted therapy and other anti-cancer therapies interval <1 month; 4. The radiotherapy plan fails to meet the minimum dose coverage and dose volume limitation requirements of target area, or the radiation dose limitation of normal organs; 5. Had received thoracic radiation therapy or radioactive seed implantation in the past; 6. Cardiac pacemakers or other metal prostheses that may be interfered with normal functions by high-energy rays or may affect the dose in the radiation target area; 7. Pregnancy (confirmed by serum or urine -HCG) or lactation period; 8. HIV positive, including history of antiretroviral therapy; Chronic hepatitis B virus replication period; Hepatitis C active period; Syphilis active stage; 9. HBV positive, hepatitis virus replication stage, need to receive antiviral treatment, but because of the accompanying disease can not receive antiviral treatment; 10. There are serious complications that may affect the conduct of radiotherapy, including: (1) Acute infectious diseases; Or acute active exacerbation of chronic infection; (2) Unstable angina, congestive heart failure, myocardial infarction requiring hospitalization in the past 6 months; (3) Exacerbations of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization; (4) Severely impaired immune function; (5) Hypersensitivity to radiation with ataxia telangiectasia; (6) during pregnancy or lactation; (7) Other diseases that may affect particle therapy; 11. No or limited capacity for civil conduct; 12. Abuse drugs or alcohol dependence, or have a history of mental illness, cannot understand the purpose of treatment or the study, or may hinder the completion of treatment; 13. Unwillingness/inability to sign informed consent; 14. Circumstances in which other physicians deem it inappropriate to participate in clinical trial.

Design outcomes

Primary

MeasureTime frame
Local control rate;

Secondary

MeasureTime frame
Progression-free survival rate;Overall survival rate;

Countries

China

Contacts

Public ContactJian Chen

Shanghai Proton and Heavy Ion Center

fathomer@163.com+86 13585859784

Outcome results

None listed

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