Randomized Phase II Study Comparing Stereotactic Body Radiotherapy (SBRT) With Stereotactic Body Proton Therapy (SBPT) for Centrally Located Stage I, Selected Stage II and Recurrent Non-Small Cell Lung Cancer
SBRT and SBPT:
Both SBRT and SBPT affect tumor cells in the same way. SBRT is the more common radiation
technique of the two being studied and has been shown to be effective. However, SBRT may
cause side effects when the tumor is close to normal organs because the photon does not stop
totally after it hits the tumor cells.
SBPT is a type of radiation that uses charged-up particles. This beam of particles can be
targeted like a laser to hit a tumor. When the beam travels through tissue, it starts to
slow down. Doctors can control how deep the radiation particles go, to make sure that enough
radiation hits the tumor being targeted and avoids the surrounding normal organs.
Both forms of radiation will be planned by a radiologist (radiation doctor) who will decide
the dosage of radiation and how it will be given. Radiation technicians will follow the
doctor's instructions to deliver your doses of radiation. Because your body moves during
radiation, both photon and proton beams sometimes may have trouble staying on target. Proton
radiation is more affected by the motion of your body than photon radiation. However, your
doctors will use many methods to reduce motion.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in a flip of the coin) to 1 of 2 groups. You will have an equal chance of being in
- If you are in Group 1, you will receive SBRT.
- If you are in Group 2, you will receive SBPT.
You will receive 4 treatments of SBRT or SBPT. During the treatment, you will lie still on a
table for about 30-45 minutes per day in the same position for 4 days in a row.
You will not feel, see, or smell anything during the photon or proton beam delivery.
If you are randomly assigned to SBPT, a member of the radiation therapy staff will place 1-5
tiny metal pellets (called fiducial markers) around the tumor to help the radiation doctor
locate the tumor during the daily proton therapy. The procedure could be done by a
bronchoscopy or using a CT-guided needle placement through the chest wall.
Once a week during the treatment:
- You will be asked about any side effects you may have had.
- You will have a physical exam.
- Your medical history will be recorded.
Length of Study:
You will finish study treatment after the 4th treatment of SBRT or SBPT. You will no longer
be able to continue the same SBRT or SBPT to the same lesion if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions during the
procedures. However, you can still receive other alternative treatments.
After the treatment, at 6 weeks, every 3 months (+/-1 month) for 2 years, every 6 months
(+/-1 month) for 3 years, and then once a year for the rest of your life you will have
follow-up. This follow-up schedule is standard of care.
You will have a physical exam. Your medical history will be recorded. You will have a chest
CT or PET scan to check the status of the disease. Blood (about 2 teaspoons) will be drawn
for routine tests.
Between 6 weeks and 6 months after treatment and then 1 time a year for 2 years, you will
have a lung function tests.
On the 3rd or 4th follow-up visit and then 1 time a year for 2 years, you will have an ECG.
A SPECT scan may be performed on the 3rd or 4th visit if the doctor thinks it is needed.
Your participation on the study will be over once you have completed the follow-up visits
for 2 years. After the 2 years follow up, you will be followed according to the standard of
care as described above. If the follow-up is at another hospital, the information about your
medical history, physical exam, lung function, PET or CT scans will be sent to MD Anderson
This is an investigational study. SBRT and SBPT are FDA approved for the treatment of lung
Up to 120 patients will take part in this multicenter study. Up to 100 will be enrolled at
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Stereotactic Body Radiotherapy (SBRT) and Stereotactic Body Proton Therapy (SBPT Related Toxicities
Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.
Joe Y. Chang, MD, MS, PHD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|UT MD Anderson Cancer Center||Houston, Texas 77030|