Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06205927

Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer

Led by Jian Chen · Updated on 2025-06-17

77

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this randomized clinical trial is to learn about if carbon ion radiotherapy dose boost in hypoxia lesions detected by 18F-Misonidazole PET/CT could improve clinical outcomes in locally advanced non-small cell lung cancer patients compared with standard treatment protocol in our center. The patients will be randomly divided into two arms: standard treatment arm and hypoxic lesions dose boost arm. The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume. The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT. Researchers will compare the local progression-free survival of two groups (primary endpoint), progression-free survival (secondary endpoint), overall survival (secondary endpoint), response rate (secondary endpoint), factional hypoxia volume (FHV) reduction rate (secondary endpoint) and toxicities (secondary endpoint).

CONDITIONS

Official Title

Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 18 and 80.
  • ECOG general status score of 0 to 2.
  • Primary non-small cell lung cancer confirmed by histology or cytology, stage IIIa to IIIc (AJCC/UICC 8th edition).
  • Largest diameter of primary tumor at least 4 cm before radiotherapy.
  • Medically inoperable or patient refuses surgery.
  • Adequate blood function: neutrophil count at least 1.5 x 10^9/L, platelet count at least 80 x 10^9/L, hemoglobin at least 9 g/dL.
  • Adequate lung function: FEV1 greater than 25%, DLCO greater than 25%.
  • Adequate cardiac function without serious pulmonary hypertension, cardiovascular or cerebrovascular diseases, peripheral vascular diseases, or serious chronic heart disease that may affect radiotherapy.
  • Adequate liver function: total bilirubin less than 1.5 times upper normal limit; AST and ALT less than 2 times upper normal limit.
  • Adequate renal function: serum creatinine less than or equal to 1.5 times upper normal limit or creatinine clearance at least 50 ml/min; urinary protein less than 2+ or 24-hour urinary protein less than or equal to 1 g if baseline is 2+ or more.
  • Signed informed consent.
Not Eligible

You will not qualify if you...

  • Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.
  • Failure to comply with treatment protocol.
  • Uncontrolled other malignant tumors.
  • Particle radiotherapy plan cannot meet minimum target dose or normal tissue dose constraints.
  • History of chest radiation therapy or radioactive particle implantation.
  • Cardiac pacemakers or internal metal implants that interfere with radiation.
  • Pregnancy or breastfeeding.
  • HIV positive, active hepatitis requiring antiviral therapy but unable to receive it, or active syphilis.
  • History of mental illness hindering treatment completion.
  • Serious comorbidities impacting radiotherapy, including acute infections, recent heart conditions, severe respiratory disease requiring hospitalization, severely impaired immune function, diseases highly sensitive to radiation, or other conditions affecting particle radiotherapy.
  • Other conditions deemed inappropriate by the physician.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China, 201513

Actively Recruiting

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Research Team

J

Jing Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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