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NCT Number: NCT00875901

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

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 information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion 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.

Treatment and study plan

Peripherally located lung tumor

Radiation

12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)

Other names: Proton Radiation

Centrally located lung tumor

Radiation

6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)

Other names: Proton Radiation

Primary outcomes

  1. Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.

    Time frame: 1 year after the end of radiation therapy

Secondary outcomes

  1. Collect and analyze outcome data on tumor control and survival

    Time frame: When each patient has been followed for a minimum of 12 months to a maximum of 5 years

  2. Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus

    Time frame: When each patient has been followed for a minimum of 12 months to a maximum of 5 years

  3. Assess changes in quality of life before and after treatment

    Time frame: Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer

Acronym: LU03

Important dates

Study start
2009
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2009
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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