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TerminatedNot applicableNCT00881712
Official study title

Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)

Study summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPET positive nodal disease measuring 15 mm or greater and PET positive nodal disease measuring less than 15 mm

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 Sep 11, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

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: PET positive nodal disease measuring 15 mm or greater; Radiation: PET positive nodal disease measuring less than 15 mm; Radiation: Patients considered resectable
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
Locally advanced→
Treatment approach
Chemotherapy→Radiation therapy→
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
  • Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
  • Patient must be at least 18 years old at the time of consent.
  • Stage III A or III B disease.
  • Patients must be able to start study treatment within 6 weeks of study enrollment.
  • Induction chemotherapy is allowed.
  • Marginally resectable or unresectable at presentation.
  • If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.
Reasons someone may not be able to joinExclusion criteria
  • Evidence of distant metastasis.
  • Prior thoracic radiotherapy.
  • Any history of allergic reaction to taxanes.
  • Prior tumor resection. Candidate for upfront curative surgery.
  • Pleural effusion visible on chest x-ray or the scout view of the CT chest.
  • Unintentional weight loss within the month prior to diagnosis ≥ 10%.
  • Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
  • The presence of PET positive contralateral hilar disease.

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: Sep 11, 2017. Always confirm current availability with the study team.

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