Carbon ion therapy for advanced lung cancer with hypoxic lesions

Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients With Non-Small Cell Lung Cancer

This study tests if a stronger type of carbon ion therapy can help people with advanced lung cancer that has hard-to-treat areas, compared to standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Proton and Heavy Ion Center (other)
• Drugs / interventions: bevacizumab, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06205927 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of carbon ion radiotherapy with a dose boost for hypoxic lesions in patients with locally advanced non-small cell lung cancer (NSCLC). Participants will be randomly assigned to receive either standard carbon ion therapy or an enhanced dose targeting hypoxic areas identified through 18F-Misonidazole PET/CT imaging. The primary focus is to compare local progression-free survival between the two treatment groups. Secondary outcomes include overall survival and response rates to the therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage IIIa-IIIc non-small cell lung cancer who are medically inoperable or refuse surgery.

Not a fit: Patients with early-stage lung cancer or those who are operable may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved clinical outcomes for patients with advanced lung cancer by specifically targeting hypoxic tumor regions.

How similar studies have performed: While the use of carbon ion therapy is established, this specific approach targeting hypoxic lesions is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Between the ages of 18 and 80.
* ECOG general status score of 0-2 .
* Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, stage IIIa-IIIc (AJCC/UICC 8th edition). Largest diameter of primary tumor ≥ 4cm before carbon ion radiotherapy.
* Medically inoperable, or patient refuses surgery.
* Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1\>25%, DLCO\>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \<1.5 times the upper limit of normal value, and AST, ALT\<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein \<2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.
* Sign the informed consent.

Exclusion Criteria:

* Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.
* Patient fails to comply with the treatment protocol.
* Complicated with other malignant tumors that have not been controlled.
* Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
* Chest radiation therapy or radioactive particle implantation history.
* Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.
* Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
* HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
* A history of mental illness may hinder the completion of treatment.
* With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.
* Other circumstances that the physician considers inappropriate to participate in clinical study.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Proton and Heavy Ion Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jing Li

Conditions: Non-small Cell Lung Cancer, 18Fluoro-misonidazole, hypoxia, particle therapy, carbon-ion radiotherapy, non-small cell lung cancer