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

University of Texas Southwestern Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

hypofractionated radiation therapyRADIATION

hypofractionated radiation therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (2)

Stanford University

Stanford, California, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Dose-limiting toxicity

Time frame: 90 days

Secondary Outcomes

Local regional tumor control

Time frame: 6 month

Overall survival

Time frame: 2 year

Data from ClinicalTrials.gov

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