Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:October 2009
Contact:Robert Timmerman, MD
Phone:214-645-8525

Use our guide to learn which trials are right for you!

Phase 1 Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status


RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of specialized
radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent
non-small cell lung cancer and poor performance status.


OBJECTIVES:

Primary

- To escalate the dose of accelerated hypofractionated image-guided conformal
radiotherapy to a potent tumoricidal dose without exceeding the maximum-tolerated dose
in patients with recurrent or stage II-IV non-small cell lung cancer and poor
performance status.

Secondary

- To evaluate local regional tumor control and overall survival of patients treated with
this regimen.

OUTLINE: Patients undergo accelerated hypofractionated image-guided conformal radiotherapy
once daily, 5 days a week, for 3 weeks (15 fractions). Treatment continues in the absence of
disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for up to 5 years.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Stage II-IV and/or recurrent disease

- No small cell histology

- Measurable or evaluable disease

- Tumor not amenable to surgical resection

- Tumor not eligible for stereotactic body radiation therapy

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiation therapy fields

PATIENT CHARACTERISTICS:

- Zubrod performance status 2-4

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must agree to use effective contraception

- Must complete all required pretreatment evaluations

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 1 week since prior chemotherapy or chemoradiation therapy

- No concurrent chemotherapy

- No other concurrent antineoplastic therapy (including standard-fractionated
radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and
surgery) 1 week before, during, and for 1 week after completion of study therapy
We found this trial at
2
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials