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Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00843726
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 12, 2009
First Posted Date  ICMJE February 13, 2009
Results First Submitted Date  ICMJE April 15, 2021
Results First Posted Date  ICMJE June 15, 2021
Last Update Posted Date June 15, 2021
Actual Study Start Date  ICMJE September 12, 2008
Actual Primary Completion Date May 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2021)
  • Incidence of AE Grade 3 or Higher Toxicity [ Time Frame: 1year ]
    Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
  • Overall Survival [ Time Frame: 5 years ]
    Median overall survival
  • Correlation Between Blood and Serum Markers and Survival and Toxicity [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • Incidence of RTOG grade 3 or higher toxicity
  • Overall Survival
  • Correlation Between Blood and Serum Markers and Survival and Toxicity
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer
Brief Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

  • To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.

Secondary

  • To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
  • To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.

OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
  • Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires

Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.

After completion of study treatment, patients are followed for 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Radiation: Arm 1 stereotactic body radiation therapy
    Patients undergo 1 high-dose fraction
  • Radiation: Arm II stereotactic body radiation therapy
    Patients undergo 3 high-dose fractions
Study Arms  ICMJE
  • Experimental: Arm I
    Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
    Intervention: Radiation: Arm 1 stereotactic body radiation therapy
  • Experimental: Arm II
    Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
    Intervention: Radiation: Arm II stereotactic body radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2009)
98
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 6, 2020
Actual Primary Completion Date May 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer
  • T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
  • Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
  • Age >= 18

Exclusion Criteria:

  • Prior thoracic radiation therapy
  • T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
  • Node positive or metastatic disease
  • Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
  • No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
  • Pregnant or unwilling to use adequate contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00843726
Other Study ID Numbers  ICMJE I 124407
I 124407 ( Other Identifier: Roswell Park Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP