search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Arm 1 stereotactic body radiation therapy
Arm II stereotactic body radiation therapy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute
  • SUNY Upstate Medical University
  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

Outcomes

Primary Outcome Measures

Incidence of AE Grade 3 or Higher Toxicity
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
Median overall survival
Correlation Between Blood and Serum Markers and Survival and Toxicity

Secondary Outcome Measures

Full Information

First Posted
February 12, 2009
Last Updated
May 20, 2021
Sponsor
Roswell Park Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00843726
Brief Title
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2008 (Actual)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
May 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Intervention Type
Radiation
Intervention Name(s)
Arm 1 stereotactic body radiation therapy
Intervention Description
Patients undergo 1 high-dose fraction
Intervention Type
Radiation
Intervention Name(s)
Arm II stereotactic body radiation therapy
Intervention Description
Patients undergo 3 high-dose fractions
Primary Outcome Measure Information:
Title
Incidence of AE Grade 3 or Higher Toxicity
Description
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.
Time Frame
1year
Title
Overall Survival
Description
Median overall survival
Time Frame
5 years
Title
Correlation Between Blood and Serum Markers and Survival and Toxicity
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag K. Singh, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs