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The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.
Proton therapy is a type of radiation therapy that uses a beam of protons particles (similar to getting an x-ray) to send radiation inside the body to the tumor. IGAPT is a therapy that uses images to help guide the delivery of the photon treatment to specific locations in the body. This newer type of radiation helps doctors to give a full dose of treatment to the tumor while not damaging as much of the healthy tissue around it.
If you are found to be eligible to take part in this study, you will go through the standard radiation treatment planning procedure, called the "marking session." During the marking session, a standard photon therapy plan will be developed. If the radiation oncologist thinks the photon therapy plan is acceptable, you will then be randomly assigned to 1 of 2 groups. Participants in Group 1 will receive photon therapy. Participants in Group 2 will receive proton therapy. The first 20 participants will have equal chance to be assigned to either group. The radiation oncologist will then study the risk of pneumonitis and/or tumor recurrence in the first 20 patients and use that information to decide which treatment appears to be better. Everyone who joins the study from that point on will be more likely to be assigned to receive the type of therapy that the radiation oncologist considers to be better.
If the tumor is too large and the standard radiation treatment plan created during the marking session is found not to be acceptable, and the radiation oncologist thinks radiation treatment it is necessary, you will still remain on study and be assigned to a third group. If you are assigned to Group 3, you will receive proton treatment at a lower dose level and/or reduced length of radiation.
Radiation Therapy Administration:
Both radiation therapy treatments (photon and proton) are given through a radiation machine called an accelerator. The radiation therapy administration process is very similar to the way that a CT scan is performed. You will lay on a table and the treatment machine rotates around you without touching your body. Each daily treatment should take about 20-30 minutes to complete. Most of this time is used to position you correctly before the machine is turned on. The actual time used to give the radiation should take about 3-5 minutes each day.
While you are on this study and if you are in Groups 1 or 2, you will receive a total of 37 radiation treatments. Radiation is given 5 days a week for about 7 1/2 weeks.
- If you are in Group 1, you will receive photon radiation treatment in the main hospital.
- If you are in Group 2, you will receive proton therapy in the proton treatment center (PTC).
- If you are in Group 3, you will receive proton therapy in the PTC for 6-7 1/2 weeks.
Study Visits During Chemoradiation:
At least 1 time each week for all study participants, you will have study tests performed. During this weekly study visit, the following tests and procedures will be performed:
- You will have a physical exam.
- You will be asked about any side effects you may have experienced.
- Blood (about 2 teaspoons) will be drawn for routine tests.
If the medical oncologist thinks it is necessary, the following image scans will be performed at any time during this study:
- You will have a CT or MRI scan of the chest and abdomen.
- You will have a cardiac SPECT scan performed.
- You will have a lung SPECT scan performed.
- You will have a chest x-ray performed.
- You will have a bone scan performed.
Length of Study:
You will remain on study as long you are benefiting. You will be taken off study early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to receive the study treatment.
After you have completed chemoradiation, the study staff or study nurse will contact you 1 time each month to ask you about any symptoms you may have. Each phone call should last about 10 minutes.
You will have your first follow-up visit 4-8 weeks after you have completed chemoradiation. You will have additional follow-up visits every 3-4 months for 3 years, every 6 months for the next 2 years, and then 1 time every year after that.
At the first and second follow-up visit the following tests and procedures will be performed:
- You will have positron emission tomography (PET)/computed tomography (CT) scans and single proton emission tomography (SPECT) scans to check the status of your lungs and heart if the radiation or medical oncologist thinks it is necessary.
- Blood (about 1 teaspoon) will be drawn for routine tests.
If the radiation oncologist or medical oncologist thinks it is needed, at the follow-up visits, you will have breathing function tests performed to check your lung function for up to 1 year after the study treatment is complete. For this test, the radiation oncologist, medical oncologist or study nurse will have you breathe into a special machine. The radiation oncologist or medical oncologist will decide how many tests are to be performed each time.
PET/CT and SPECT scans will be performed again at any time the radiation oncologist or medical oncologist thinks they are needed.
Other tests may be performed if the study doctor (radiation oncologist, medical oncologist, surgeon or pulmonologist) thinks they are needed.
This is an investigational study. Both proton radiotherapy and IGAPT are FDA approved for the treatment of lung cancer.
Up to 168 patients will take part in this multicenter research study. Up to 150 will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
Photon Therapy, Proton Therapy
Massachusetts General Hospital
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:21:43-0400
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