Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer

Completed · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT01459497

Run by

University of Texas Southwestern Medical Center

People needed

103

Starts

2012-10-01

Expected to finish

2023-10-19

Last updated by the study team

2024-01-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Georgetown Cancer Center (Austin Cancer Center) — Austin, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• Baylor Research Institute Dallas, Baylor Irving — Irving, Texas, United States
• Texas Oncology - Sherman — Sherman, Texas, United States
• Scott & White Memorial Temple — Temple, Texas, United States
• Texas Oncology - Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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