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SRS Study in Patients With Non-Small Cell Lung Cancer

NCT00489008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2020-03-30

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be studied.

Objectives:

To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC).

Primary goal: Improve 2 years progression free survival at the treated primary tumor site.

Secondary goals:

1. Improve disease free survival, disease specific survival and overall survival at 2 years.
2. Decrease grade 3 and above acute and/or chronic toxicities.
3. Collect blood for future biomarkers study

Conditions

Interventions

PROCEDURE

Stereotactic Body Radiation Therapy (SBRT)

Cohorts 1 \& 2: 50 gray (GY) with 12.5 GY per Fraction for 4 treatments Cohort 3: 40 GY with 10 GY per Fraction for 4 treatments

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Joe Y. Chang, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-21
Primary Completion
2017-06-02
Completion
2017-06-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00489008 on ClinicalTrials.gov