Clinical trial: NCT01753414
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?

Taking part in this study may or may not make your health better. While researchers hope the study will help determine if SBRT is as effective as surgery in treating lung cancer, with less side effects. We do know that the information from this study will help researchers learn more about SBRT as a treatment for cancer. This information could help future cancer patients.

Your other choices may include:
- Getting treatment or care for your cancer without being in a study
- Taking part in another study
- Getting no treatment Talk to your study doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT01753414
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private?

Data are housed at RTOG Headquarters in a password-protected database. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
- The Radiation Therapy Oncology Group (RTOG)
- China POSTILV Trial Group - The Institutional Review Boards (IRB) associated with this study. The IRBs are groups of people who review the research with the goal of protecting the people who take part in the study.
Clinical trial: NCT01753414
Section: Duration of Study Involvement
Subsections: Before You Begin The Study:|4-6 Weeks After Surgery Or Sbrt

You will need to have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
- Physical examinations by several doctors - Checking your weight - Evaluation of your ability to carry out daily activities - A PET (Positron Emission Tomography) scan of your body: A small amount of radioactive material is injected into your vein, and a scanner makes a detailed picture of areas inside your body
- A CT (Computed Tomography) scan of your lungs and abdomen with contrast: a CT scan is a study using x-rays to look at one part of your body. Contrast means that dye is injected into your vein to increase the differences between normal and abnormal tissue.  
- Tests of your breathing and lung function - For women who are able to have children, a test to see that they are not pregnant - Endobronchial Ultrasound: A tube is inserted through your mouth or nose in the airway leading to your lungs. After the tube is in place, the doctor uses a probe to send sound waves into the lungs to make an image. To obtain tissue or fluids from the lungs, the doctor uses a small needle or probe. This procedure may require you to have anesthesia.

- Physical examinations by several doctors - Checking your weight - Evaluation of your ability to carry out daily activities - Evaluation of any side effects from treatment you may be having
Clinical trial: NCT01753414
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.  
We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data related to this study. The Committee members may receive confidential patient information, but they will not receive your name or other information that would allow them to identify you by name. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT01753414
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study?|Less Likely|Rare But Serious|Risks And Side Effects Related To The Sbrt Likely|Rare But Serious.|Reproductive Risks:|What Happens If I Am Injured Because I Took Part In This Study?|Risks

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, researchers don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after surgery or SBRT. In some cases, side effects can be serious, long lasting, or may never go away. There also is a risk of death. You should talk to your study doctor about any side effects that you have while taking part in the study.

- Lung infection/pneumonia - A blood clot in the lung - A blood clot in a large vein, which could result in a stroke or a heart attack in some cases
- Prolonged need for a tube placed in your airway to help you breath during the surgery for longer than 24 hours after surgery is finished or
- Replacing the tube in your airway after it is initially taken out - Wound infection - Leakage of air from the lung after your lung cancer has been removed - Injury to the nerves of your voice box (larynx), which may result in hoarseness or difficulty swallowing
- Changes in tests that show how your lungs are working

- Sepsis (a severe form of infection) - Heart attack - Irregular or rapid heartbeat
- Severe inflammation of the lung, which can affect your ability to breath normally
- Injury to a blood vessel that can result in heavy bleeding during or after surgery

- Damage to surrounding normal lung and/or collapse of a portion of treated lung - Changes in the lungs as the tumor shrinks; these changes will be recognized by your radiation doctor on your x-rays or scans as expected "scarring" that is developing. In most patients, no noticeable symptoms will result from this lung damage.  
- Fatigue - Redness of irritation of the skin in the treatment - Hair loss in the treatment area (chest hair) - Some soreness of the ribs with an increased risk of rib fracture. Treatment for such symptoms usually consists of rest, heat, and pain medication.

- Some patients can have the following symptoms associated with lung scarring:
shortness of breath, cough, fever, and/or pain in the chest wall. These patients may require oxygen for a short time or permanently. Lung damage can be life threatening.  
- Damage to the lining of the heart, which can cause fluid accumulation around the heart and chest pain, shortness of breath, and/or irregular or rapid heart beat
- Damage to the heart muscle, which can cause heart attack, heart failure, or death
- Damage to the spinal cord, which can cause numbness, weakness, tingling, and/or inability to use the arms and/or legs
- Damage to the esophagus, which can cause problems with swallowing - Damage to the large blood vessels surrounding the heart, which could cause coughing up of blood and possibly death
- Severe pain or skin damage leading to an open wound During the process of treatment planning and radiation, you will lie in a specific position, possibly within a frame device, and some patients can become claustrophobic. Medications can be given to make you feel more comfortable should this happen. Also, your doctor may give you pain medication before each treatment to decrease any discomfort you may have due
*Page 7* to laying on a hard surface and/or due to laying with your arms held above your head during the treatment.

This study may be harmful to a nursing infant or an unborn child. If you are a woman able to have children and have not been surgically sterilized (tubal ligation or hysterectomy), you must have a pregnancy test before enrolling in this study. If you are unwilling to use adequate birth control measures to prevent pregnancy, you should not participate in this study. If you should become pregnant while you are on this study, you must tell your doctor immediately. If you are a man able to father children, the treatment you may receive may risk harm to an unborn child unless you use a form of birth control approved by your doctor. If you are unwilling to use adequate birth control measure to prevent pregnancy you should not participate in this study. If you suspect you have caused anyone to become pregnant while you are on this study, you must tell your doctor immediately.  
For more information about risks and side effects, ask your study doctor.

It is important that you tell your study doctor, __________________ [investigator's name(s)], if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at __________________ [telephone number]. You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is small.
Clinical trial: NCT01753414
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study?|During The Study:|You Will Need These Tests And Procedures In Follow-Up Visits:|Study Plan

You will have a PET/CT scan to see if you can take part in this study. If the scan shows that you cannot take part, your doctor will talk with you about other treatments. If the scan shows that you can take part in the study, you will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in one of the groups. If you are in group 1 (often called "Arm A"): You will have surgery to remove all or most of the lung cancer and one lobe (section) of the lung. If you are in group 2 (often called "Arm B"): You will have SBRT, once every other day for 5 treatments. Before SBRT begins, you will have a treatment planning session. You will lie in a specific position, possibly within a frame device or on a large plastic bag filled with tiny foam balls similar to a bean bag. The purpose of the frame or bag is to hold your body as still as possible for planning and treatment. After you are positioned, doctors will check your breathing and see how your tumor and organs move. The doctors will try to limit the effect of that movement on the position of your tumor by timing your breathing. They may use a device to control the depth of your breathing or one to monitor the rate and pattern of your breathing so that they will be able to deliver the radiation to the tumor while accounting for the effect of breathing. Radiation Treatment: Usually 7-10 days after the radiation planning session, you will return to the radiation medicine department for your radiation treatment. For your treatment, you will lie in the device that was used for your planning session. You will lie as still as possible and breathe normally (or have your breathing controlled by a device) while your radiation is delivered. It will take approximately one to two hours to deliver the radiation. During the process of radiation, participants can become claustrophobic. Medications can be given to make you feel more comfortable should this happen. Also, your doctor may give you pain medication before each treatment to decrease any discomfort you may have due to laying on a hard surface and/or due to laying with your arms held above your head during the treatment.

If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will need the following tests and procedures. They are part of regular cancer care. For Group 2 patients after SBRT is completed: Evaluation of any side effects from treatment you may be having

At 3, 6, 9, 12, 18, 24 and 36 months after treatment: A CT (Computed Tomography) scan of your lungs and abdomen with contrast At 3, 12, and 24 months after treatment: A PET (Positron Emission Tomography) scan of your body Every 3 months for years 1-2 years, every 6 months for year 3, then yearly for your lifetime:
- Physical examination - Checking your weight - Evaluation of your ability to carry out daily activities - Evaluation of any side effects from treatment you may be having - If your doctor recommends, tests of your breathing and lung function

Another way to find out what will happen to you during the study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.  
After your treatment is completed, you will be seen in follow-up visits every 3 months for years 1-2 years, every 6 months for year 3, then once a year for 2 years, for a total of 5 years of follow up from the time you begin treatment.  
  
How long will I be in the study?
Group 1 patients will receive surgery. Group 2 patients will receive 1 SBRT treatment every other day for 5 treatments.
Clinical trial: NCT01753414
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Benefits

The standard treatment for your type of cancer is surgery. The purpose of this study is to compare surgery to stereotactic body radiation therapy (SBRT) to see the effects these treatments have on you and your lung cancer. SBRT may have fewer side effects than surgery, but we do not know if SBRT is as effective at removing your cancer or preventing it from returning. SBRT is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. The technique of giving a higher effective dose per treatment may work better to kill cancer cells potentially with fewer side effects than standard radiation therapy. SBRT uses special equipment to position the patient and guide focused xray beams toward the cancer and away from normal lung tissue. Research so far suggests that SBRT can reduce the size or eventually eliminate lung tumors effectively and is relatively safe for lungs and other organs in your body.

The benefits of research using tissue and blood include learning more about what causes cancer and other diseases, how to prevent them, and how to treat them.
Clinical trial: NCT01753414
Section: Voluntary Participation
Subsections: Making Your Choice

Please read each sentence below and think about your choice. After reading each sentence, circle "Yes" or "No". If you have any questions, please talk to your doctor or nurse, or call our research review board at __________________________ [IRB's phone number]. No matter what you decide to do, it will not affect your care.  
1. My specimens may be kept for use in research to learn about, prevent, or treat cancer, as follows:
- Tissue Yes  No - Blood Yes  No 2. My specimens may be kept for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease), as follows:
- Tissue Yes  No - Blood Yes  No 3. Someone may contact me in the future to ask me to take part in more research.  
Yes  No You will get a copy of this form. If you want more information about this study, ask your study doctor.
Clinical trial: NCT01753414
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. It is important to tell the study doctor if you are thinking about stopping so any risks from the surgery or SBRT can be evaluated by him/her. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest; if you do not follow the study rules; or if the study is stopped.