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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: Arm 1 stereotactic body radiation therapy; Radiation: Arm II stereotactic body radiation therapy

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: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).	Radiation: Arm 1 stereotactic body radiation therapy; Patients undergo 1 high-dose fraction
Experimental: Arm II; Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.	Radiation: Arm II stereotactic body radiation therapy; Patients undergo 3 high-dose fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1year
Overall Survival	Median overall survival	5 years
Correlation Between Blood and Serum Markers and Survival and Toxicity		4 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2008
• Primary Completion (Actual): May 6, 2020
• Study Completion (Actual): May 6, 2020

Study Registration Dates

• First Submitted: February 12, 2009
• First Submitted That Met QC Criteria: February 12, 2009
• First Posted (Estimate): February 13, 2009

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: I 124407 (Other Identifier: Roswell Park Cancer Institute)