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CompletedNot applicableNCT00875901
Official study title

Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)

Study summary

This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPeripherally located lung tumor and Centrally located lung tumor

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 Mar 24, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Florida

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
University of Florida
Interventions being studied
Radiation: Peripherally located lung tumor; Radiation: Centrally located lung tumor
02
Explore related studies

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→Surgery→
03
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
  • Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma diagnosed within 3 months prior to study enrollment.
  • T1, N0, M0 or T2, N0, M0. (AJCC Lung 7th Edition)
  • At least 18 years old at the time of consent.
  • Adequate bone marrow function.
  • Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection.
  • If the patient has a large pleural effusion, it must be biopsy negative.
Reasons someone may not be able to joinExclusion criteria
  • Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).
  • Synchronous primary.
  • T2 tumors \> 5 cm; T3, T4 primary tumor.
  • Previous radiotherapy for lung cancer.
  • Concomitant local, regional, and/or systemic therapy during radiotherapy.
  • Active systemic, pulmonary, and/or pericardial infection.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Florida Proton Therapy InstituteJacksonville, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 24, 2022. Always confirm current availability with the study team.

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