Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
non-small cell lung cancer, Stages II or III non-small cell lung cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiation Therapy Type: Radiation
Name: Conventional radiation Type: Radiation
Overall Status
Recruiting
Summary
The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- All patients must be willing and capable to provide informed consent to participate in the protocol.

- Patients must have appropriate staging studies identifying them as AJCC stage II or III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology within 6 months of study entry.

- Patients must have the potential for benefit from local therapy (at the discretion of the investigator).

- The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod performance status 0-1 and weight loss >10% are considered eligible. In addition, patients determined to be medically unfit or refusing combined modality therapy are eligible.

- Age ≥ 18.

- Patients must have measurable or evaluable disease.

- Women of childbearing potential and male participants must agree to use an effective method of contraception.

- Patients must sign study specific informed consent prior to study entry.

- Patients must not have plans for concurrent chemoradiation therapy.

- Patients must complete all required pretreatment evaluations

Exclusion Criteria:

- Total (aggregate) gross tumor volume > 500 cm3 (500 cc's or 0.5 Liters)

- Prior radiotherapy to the region of the study cancer that would result in direct overlap of radiation therapy fields.

- Chemotherapy given within one week of study registration.

- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
Location
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Start Date
October 2012
Completion Date
December 2018
Sponsors
University of Texas Southwestern Medical Center
Source
University of Texas Southwestern Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page