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

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.

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

Undergo image-guided IMRT

RADIATION

Image Guided Radiation Therapy

Undergo image-guided IMPT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo image-guided IMRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo image-guided IMPT

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

RADIATION

Photon Beam Radiation Therapy

Undergo image-guided IMRT

RADIATION

Proton Beam Radiation Therapy

Undergo image-guided IMPT

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Zhongxing Liao · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-17

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States

Study Locations