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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00986297

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Radiation: hypofractionated radiation therapy	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: arm one IGRT	Radiation: hypofractionated radiation therapy hypofractionated radiation therapy Other Names: IGRT

Arm

Intervention/Treatment

Other: arm one

IGRT

Radiation: hypofractionated radiation therapy

hypofractionated radiation therapy

Other Names:

IGRT

Outcome Measures

Primary Outcome Measures

Dose-limiting toxicity [90 days]

Secondary Outcome Measures

Local regional tumor control [6 month]
Overall survival [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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