Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied. Objectives: To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC. Primary goals: 1. Improve 2 years progression free survival at the primary site, and 2. reduce acute and chronic toxicity Secondary goals: 1. Improve disease specific survival at 2 years. 2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome. 3. Study the role of biomarkers in predicting therapeutic response and toxicities.

Key facts

Study ID

NCT00495040

Run by

M.D. Anderson Cancer Center

People needed

38

Starts

2006-05-04

Expected to finish

2017-06-14

Last updated by the study team

2019-01-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented NSCLC.
• Patients with inoperable centrally located tumors, defined as those within 2 cm of the bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0 (selected stage II with chest wall involvement) NSCLC.
• Performance score KPS 60-100.

You may not qualify if…

• Prior radiotherapy to the chest.
• Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.
• Pregnancy. Patients, both men and women of child bearing potential should use an effective method of birth control throughout their participation in this study.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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