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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00986297
First received: September 26, 2009
Last updated: November 1, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: hypofractionated radiation therapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Local regional tumor control [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2009
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
arm one
IGRT
Radiation: hypofractionated radiation therapy
hypofractionated radiation therapy
Other Name: IGRT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986297

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00986297     History of Changes
Other Study ID Numbers: CDR0000654621, SCCC-05509, 072009-061
Study First Received: September 26, 2009
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014