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 currently recruiting participants.
Verified March 2014 by Roswell Park Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00843726
First received: February 12, 2009
Last updated: March 25, 2014
Last verified: March 2014
  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 ]

Estimated 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Node-negative disease
    • Peripheral disease
  • T1-T3, N0 disease measuring ≤ 5 cm

    • No T2-T3 tumors > 5 cm or T3 tumor based on chest wall involvement
  • Surgically resectable primary disease, but patient refuses surgery or is deemed to be medically inoperable
  • No metastatic disease
  • No tumor within the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • 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)

PRIOR CONCURRENT THERAPY:

  • No prior thoracic radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843726

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: AskRPCI    877-275-7724    AskRPCI@RoswellPark.org   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gregory Videtic, MD    216-444-9797      
Principal Investigator: Gregory Videtic, MD         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

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: March 25, 2014
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
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 16, 2014