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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Time Frame:

90 days

Safety Issue:

Yes

Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000654621

NCT ID:

NCT00986297

Start Date:

October 2009

Completion Date:

Related Keywords:

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

Name

Location

Stanford UniversityStanford, California  94305
University of Texas Southwestern Medical CenterDallas, Texas