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CompletedNCT00986297Updated Aug 20, 2020

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

A Phase 1 interventional study of hypofractionated radiation therapy in Lung Cancer, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by University of Texas Southwestern Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    arm one

    IGRT

    Radiation: hypofractionated radiation therapy

Interventions

  • Radiationhypofractionated radiation therapy

    hypofractionated radiation therapy

    Also known as: IGRT

06

What researchers measure

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

07

Study locations

2 sites
  • Stanford University
    Stanford, California 94305, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00986297
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 29, 2009
Start date
Oct 2009
Primary completion
Oct 2012
Last update
Aug 20, 2020

Study contacts

Robert D. Timmerman, MD
principal investigator · Simmons Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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