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Completed

NCT Number: NCT00986297

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated Radiation Therapy

Radiation

hypofractionated radiation therapy

Other names: IGRT

Primary outcomes

  1. Dose-limiting toxicity

    Time frame: 90 days

Secondary outcomes

  1. Local regional tumor control

    Time frame: 6 month

  2. Overall survival

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
First posted
Sep 29, 2009
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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