Concurrent Proton and Chemotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Study summary

The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCarboplatin and Proton Radiotherapy

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 6, 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?1 U.S. location

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: Drug: Carboplatin; Radiation: Proton Radiotherapy; Drug: Paclitaxel

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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

Locally advanced→

Treatment approach

Chemotherapy→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. Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease excluding malignant pleural effusion. 3. Performance score Karnofsky Performance Status (KPS) 70-100, Weight loss: less or equal to 10% in 6 months prior to diagnosis. 4. Patient consented for the protocol 5. Induction chemotherapy is allowed.

Reasons someone may not be able to joinExclusion criteria

1. Prior chest radiotherapy. 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 (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study. 4. Off study criteria: a) If a patient is found to have distant metastasis during treatment and/or immediate after the treatment (\<60 days) indicating inaccurate cancer stage, he or she will be taken off study. b) If a patient does not follow up at MD Anderson and does not forward his or her medical records such as CT, PET/CT, pulmonary function test (PFT) or pathology report as required by protocol, he or she will be taken off study. c) If a patient does not have any required post-treatment evaluation such as images, he or she will be taken off 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

University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 6, 2019. Always confirm current availability with the study team.

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