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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedProton Radiotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 14, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Treatment approach

Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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