Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
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.
Checked against the public recordLast updated Jan 14, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- M.D. Anderson Cancer Center
- Interventions being studied
- Radiation: Proton Radiotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Histologically or cytologically documented NSCLC. 2. 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. 3. Performance score KPS 60-100. Exclusion Criteria: 1. Prior radiotherapy to the chest. 2. 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. 3. Pregnancy. Patients, both men and women of child bearing potential should use an effective method of birth control throughout their participation in this study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Massachusetts General HospitalBoston, Massachusetts
- University of Texas MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 14, 2019. Always confirm current availability with the study team.