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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843726
• Other study ID #: I 124407
• Secondary ID: I 124407
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2008
• Est. completion date: May 6, 2020

Study information

• Verified date: May 2021
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Arm 1 stereotactic body radiation therapy
Patients undergo 1 high-dose fraction
• Arm II stereotactic body radiation therapy
Patients undergo 3 high-dose fractions

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall Survival	Median overall survival	5 years
Primary	Correlation Between Blood and Serum Markers and Survival and Toxicity		4 years