Using advanced radiation therapy techniques to treat stage II-IIIB non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of image-guided, intensity-modulated photon and proton beam radiation therapy in patients with stage II-IIIB non-small cell lung cancer. The study aims to determine the maximum tolerated dose of these therapies while minimizing damage to surrounding healthy tissue. It includes a comparison of treatment-related toxicity and local progression-free survival between the two radiation methods. Additionally, the trial will assess various biomarkers and symptom burden throughout the treatment process.

Why it matters

Who can join: the full rules

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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Zhongxing Liao — M.D. Anderson Cancer Center
• Study coordinator: Zhongxing Liao
• Email: zliao@mdanderson.org
• Phone: 713-563-2300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.