Clinical trial NCT00875901: Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
Official title: Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung Cancer
Stage I Non-Small Cell Lung Cancer
Proton Radiation
HypoIGRT
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
timeFrame: 1 year after the end of radiation therapy
Secondary outcomes:
measure: Collect and analyze outcome data on tumor control and survival
timeFrame: When each patient has been followed for a minimum of 12 months to a maximum of 5 years
measure: Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus
timeFrame: When each patient has been followed for a minimum of 12 months to a maximum of 5 years
measure: Assess changes in quality of life before and after treatment
timeFrame: Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Romaine C Nichols, MD
role: PRINCIPAL_INVESTIGATOR
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