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

NCT ID: NCT00843726

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-12
• Study Completion Date: 2020-05-06

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

Arm 1 stereotactic body radiation therapy

Intervention Type: RADIATION

Patients undergo 1 high-dose fraction

Arm II

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

Group Type: EXPERIMENTAL

Arm II stereotactic body radiation therapy

Intervention Type: RADIATION

Patients undergo 3 high-dose fractions

Interventions

Arm 1 stereotactic body radiation therapy

Patients undergo 1 high-dose fraction

Intervention Type: RADIATION

Arm II stereotactic body radiation therapy

Patients undergo 3 high-dose fractions

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag K. Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I 124407

Identifier Type: OTHER

Identifier Source: secondary_id

I 124407

Identifier Type: -

Identifier Source: org_study_id