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

NCT00495040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-01-14

Study results available
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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.

Conditions

Interventions

RADIATION

Proton Radiotherapy

87.5 CGE with 2.5 Gy/fraction for 35 treatments

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-04
Primary Completion
2017-06-14
Completion
2017-06-14

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 NCT00495040 on ClinicalTrials.gov