Lung Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT00986297

Recruitment Status:

Completed

Sponsor:

University of Texas Southwestern Medical Center

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There are 2 Locations for this study

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Stanford University
Stanford California, 94305, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT00986297

Recruitment Status:

Completed

Sponsor:


University of Texas Southwestern Medical Center

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