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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripherally located lung tumor | Experimental | 12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent |
|
| Centrally located lung tumor | Experimental | 6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romaine C Nichols, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18287387 | Background | Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. | |
| 9332915 | Background | al-Kattan K, Sepsas E, Fountain SW, Townsend ER. Disease recurrence after resection for stage I lung cancer. Eur J Cardiothorac Surg. 1997 Sep;12(3):380-4. doi: 10.1016/s1010-7940(97)00198-x. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
| 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) |
|
|
| 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 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |