Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment stereotactic body radiation therapy
Phase phase 2
Sponsor Roswell Park Cancer Institute
Start date September 2008
End date April 2020
Trial size 98 participants
Trial identifier NCT00843726, I 124407

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy
Patients undergo 1 or 3 high-dose fractions
(Experimental)
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy
Patients undergo 1 or 3 high-dose fractions

Primary Outcomes

Measure
Incidence of RTOG grade 3 or higher toxicity
time frame: 1year
Overall survival
time frame: 5 years
Correlation between blood and serum markers and survival and toxicity
time frame: 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Anurag K. Singh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Roswell Park Cancer Institute.