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: May 4, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Incidence of RTOG grade 3 or higher toxicity [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Correlation between blood and serum markers and survival and toxicity [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: September 2008
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
Radiation: stereotactic body radiation therapy
Patients undergo 1 or 3 high-dose fractions
Experimental: Arm II
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Radiation: stereotactic body radiation therapy
Patients undergo 1 or 3 high-dose fractions

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843726

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00843726     History of Changes
Other Study ID Numbers: I 124407  I 124407 
Study First Received: February 12, 2009
Last Updated: May 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Roswell Park Cancer Institute:
stage I non-small cell lung cancer
stage II non-small cell lung cancer

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

ClinicalTrials.gov processed this record on May 26, 2016