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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986297
• Other study ID #: CDR0000654621
• Secondary ID: SCCC-05509072009
• Status: Completed
• Phase: Phase 1
• Start date: October 2009

Study information

• Verified date: May 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• hypofractionated radiation therapy
hypofractionated radiation therapy

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity		90 days
Secondary	Local regional tumor control		6 month
Secondary	Overall survival		2 year