Non-Small Cell Lung Cancer
Conditions
Keywords
Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT
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.
Interventions
RADIATIONPeripherally located lung tumor
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)
RADIATIONCentrally located lung tumor
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)
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer. | 1 year after the end of radiation therapy |
Secondary
| Measure | Time frame |
|---|---|
| Collect and analyze outcome data on tumor control and survival | When each patient has been followed for a minimum of 12 months to a maximum of 5 years |
| Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus | When each patient has been followed for a minimum of 12 months to a maximum of 5 years |
| Assess changes in quality of life before and after treatment | Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years |
Countries
United States
Outcome results
None listed