Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer

Launched by M.D. ANDERSON CANCER CENTER · Jun 26, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver radiation therapy for patients with stage II to III non-small cell lung cancer, which is a type of lung cancer that is not suitable for surgery. The trial is exploring two methods: photon beam radiation, which uses x-rays, and proton beam radiation, which uses protons to target the tumor more precisely. The goal is to find the best dose of radiation that can effectively treat the cancer while minimizing damage to the surrounding healthy tissue.

To be eligible for this trial, participants need to have a confirmed diagnosis of stage II to III non-small cell lung cancer that hasn’t been surgically removed or has come back after surgery. They should be well enough to handle chemotherapy alongside radiation and have good lung function. Participants can expect close monitoring during the treatment to assess side effects and effectiveness. It’s important to know that those who have had previous radiation in the chest area may not qualify, and all participants will need to provide informed consent, understanding that they are part of an experimental study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung cancer
• • Suitability for concurrent chemoradiation therapy per treating physician's assessment
• • Karnofsky performance status (KPS) score \>= 70
• • Weight loss \< 15% in the 3 months before diagnosis
• • Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed
• • Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) \>= 1 L is required
• • The primary tumor and/or regional lymph nodes must be evaluable radiographically
• • The gross target volume (GTV) is suitable for motion management using 4 dimensional computed tomography (4D CT), internal target volume (ITV), or respiratory gating; in addition, the target coverage and normal tissue constraints must be met as specified in protocol accounting for the respiratory motion of anatomy as a whole (not just the tumor)
• • No prior radiation to the mediastinal structures
• • Hemoglobin \>= 9.0 g/dL
• • Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• • Platelet count \>= 100,000/mm\^3
• • Total bilirubin =\< 1.5 times the upper limit of normal (ULN)
• • Alanine and aspartate transaminases (ALT and AST) =\< 2.5 times the ULN (=\< 5 x ULN for patients with liver involvement)
• • Creatinine =\< 1.5 times ULN
• • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC)
• Exclusion Criteria:
• • Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)
• • T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart
• • Pregnancy
• • Patients of childbearing potential must practice appropriate contraception
• • Patient refusal