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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
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

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Radiation: hypofractionated radiation therapy


Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: arm one<br>IGRT | Radiation: hypofractionated radiation therapy<br>* hypofractionated radiation therapy<br>* Other names: IGRT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local regional tumor control |  | 6 month | 
| Overall survival |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer