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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 16, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT01629498). This is a study registration, not published results. Lead sponsor: M.D. Anderson Cancer Center. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 146 participants (ACTUAL). Conditions: Recurrent Lung Non-Small Cell Carcinoma, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7. Interventions: RADIATION: Image Guided Radiation Therapy; RADIATION: Image Guided Radiation Therapy; RADIATION: Intensity-Modulated Radiation Therapy; RADIATION: Intensity-Modulated Radiation Therapy; OTHER: Laboratory Biomarker Analysis; RADIATION: Photon Beam Radiation Therapy; RADIATION: Proton Beam Radiation Therapy; OTHER: Questionnaire Administration. Primary outcome measures: Maximum tolerated dose (MTD) for intensity-modulated photon therapy (IMRT) (Phase I) , 90 days; MTD for intensity-modulated proton therapy (IMPT) (Phase I) , 90 days; Survival free of grade >= 3 toxicity (with a target of at least 75%) (Phase II) , 6 months; Local progression-free survival (75% at 6 months) d (Phase II) , 6 months. Brief summary: This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of delivering radiation dose when only the tumor receives dose escalation while the surrounding normal structure is kept at standard level. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator (linac). The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Both methods are designed to give a higher than standard dose of treatment to the tumor and may reduce the amount of radiation damage to healthy tissue near a tumor.