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Trial record 1 of 1 for:    NCT00843726
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Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00843726
First received: February 12, 2009
Last updated: March 15, 2017
Last verified: March 2017

February 12, 2009
March 15, 2017
September 12, 2008
April 15, 2020   (Final data collection date for primary outcome measure)
  • Incidence of RTOG grade 3 or higher toxicity [ Time Frame: 1year ]
  • Overall survival [ Time Frame: 5 years ]
  • Correlation between blood and serum markers and survival and toxicity [ Time Frame: 4 years ]
  • Incidence of RTOG grade 3 or higher toxicity
  • Overall survival
  • Correlation between blood and serum markers and survival and toxicity
Complete list of historical versions of study NCT00843726 on ClinicalTrials.gov Archive Site
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Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Lung Cancer
Radiation: stereotactic body radiation therapy
Patients undergo 1 or 3 high-dose fractions
  • Experimental: Arm I
    Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
    Intervention: Radiation: stereotactic body radiation therapy
  • Experimental: Arm II
    Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
    Intervention: Radiation: stereotactic body radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
98
April 15, 2021
April 15, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00843726
I 124407
I 124407 ( Other Identifier: Roswell Park Cancer Institute )
Yes
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Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
March 2017

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