Status:

COMPLETED

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

Lead Sponsor:

University of Texas Southwestern Medical Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

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 ...

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 w...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00986297

    Start Date

    October 1 2009

    Last Update

    August 20 2020

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Stanford University

    Stanford, California, United States, 94305

    2

    University of Texas Southwestern Medical Center

    Dallas, Texas, United States, 75390