Clinical trial: NCT01730950
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 doctors hope that adding radiation to bevacizumab will be more useful against cancer compared to bevacizumab alone, there is no proof of this yet. We do know that the information from this study will help doctors learn more about combining bevacizumab and radiation as a treatment for cancer. This information could help future cancer patients.

Clots in the arteries, causing stroke (which may cause paralysis or weakness)  
  
  
or heart attack (which may cause chest pain or shortness of breath). This risk is significantly increased in patients who are elderly or with history of diabetes  
Heart failure which may cause shortness of breath, swelling of ankles, and  
  
  
require surgery to repair  
A tear or hole (fistula) in internal organs such as the nose, throat, lungs,  
esophagus, rectum, or vagina. These conditions may cause serious infections  
or bleeding and require surgery to repair  
Sores in the throat  
Flesh-eating bacteria syndrome, an infection in the deep layers of skin  
Bleeding in the tumor, brain, belly or lungs which may cause confusion, blood  
in stool or coughing up blood  
Brain damage which may cause headache, seizure, blindness (also known as  
Reversible Posterior Leukoencephalopathy Syndrome)  
Kidney damage which may require dialysis Redness, pain or peeling of palms and soles  
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 Other chemotherapies your physician can discuss with you.  
Talk to your doctor about your choices before you decide if you will take part in this study. Will my medical information be kept private? (4/15/14) 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:
NRG Oncology The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. [Note to Informed Consent Authors: the above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]
Clinical trial: NCT01730950
Section: Duration of Study Involvement
Subsections: During The Study …|How Long Will I Be In The Study?

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.  
Physical examination Neurologic examination Evaluation of your ability to carry out daily activities Laboratory tests for blood count and evaluation of urine MRI/CT scan Blood pressure monitoring 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 doctor can choose the group you will be in. You will have an equal chance of being placed in either group.  
If you are in group 1 (often called "Arm 1"), you will receive bevacizumab alone. The bevacizumab will be given by vein (intravenously) every 2 weeks for as long as it is working and there are no intolerable side effects.. If you are in group 2 (often called "Arm 2"), you will receive bevacizumab and radiation therapy. The bevacizumab will be given by vein (intravenously) every 2 weeks for as long as it is working and there are no intolerable side effects. You will receive 10 treatments of radiation, which will be delivered daily (typically 5 treatments per week), for 2 weeks.

If you are in Group 1, you will be asked to take bevacizumab alone every two weeks as long as it is working and there are no intolerable side effects. If you are in Group 2, you will take bevacizumab 2 weeks before radiation therapy, during radiation therapy, and then every 2 weeks after radiation therapy as long as it is working and there are no intolerable side effects. The radiation will be given to you over 2 weeks. You will be followed every 8 weeks while on treatment and then also if you are removed from protocol treatment. Follow-up will continue every 8 weeks for 1 year, then every 6 months for 1 year, then annually. If you are unable to be seen in clinic by your study doctor, you may be contacted by the study doctor or the clinic staff.
Clinical trial: NCT01730950
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.  
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: NCT01730950
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study? (10/3/16)|Possible Side Effects Of Radiation To The Brain (6/23/14) Common, Some May Be Serious|Rare, And Serious|Rare, And Serious|Possible Side Effects Of Bevacizumab (10/3/16)|Rare, And Serious|Rare, And Serious|What Happens If I Am Injured Because I Took Part In This Study?|Risks (11/20/13)

If you choose to take part in this study, there is a risk that:
You may lose time at work or home and spend more time in the hospital or doctor's office than usual You may be asked sensitive or private questions which you normally do not discuss The radiation and bevacizumab used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will be testing your blood and will let you know if changes occur that may affect your health. There is also a risk that you could have side effects from the study drug(s)/study approach. Here are important points about side effects:
The study doctors do not know who will or will not have side effects.  
Some side effects may go away soon, some may last a long time, or some may never go away.  
Some side effects may interfere with your ability to have children.  
Some side effects may be serious and may even result in death.  
Here are important points about how you and the study doctor can make side effects less of a problem:
Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.  
The study doctor may be able to treat some side effects.  
The study doctor may adjust the study drugs to try to reduce side effects.  
The tables below show the most common and the most serious side effects that researchers know about. There might be other side effects that researchers do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

In 100 people receiving radiation to the brain, more than 20 and up to 100 may have:
Scalp redness or soreness Hair loss, which may be temporary or permanent Ear/ear canal reactions, possibly resulting in a short-term hearing loss Fatigue Lethargy Temporary aggravation of brain tumor symptoms such as headaches, seizures, or weakness OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving radiation to the brain, from 4 to 20 may have:
Mental slowing Permanent hearing loss Cataracts Behavioral change Nausea Vomiting Temporary worsening of existing neurological deficits, such as decreased vision, drowsiness, and weakness of your arms and legs Endocrine problems causing abnormalities in the level of some hormones related to changes to the pituitary gland Dry mouth or altered taste

In 100 people receiving radiation to the brain, 3 or fewer may have:
Severe local damage to normal brain tissue, a condition called necrosis (tissue deterioration). Radiation necrosis can mimic recurrent brain tumor and may require surgery for diagnosis and treatment.  
Injury to the eyes with the possibility of blindness Development of other tumors (either benign or malignant)

In 100 people receiving bevacizumab, 3 or fewer may have:
Additional Notes on Possible Side Effects for Bevacizumab:
- Risk in children or adolescents: abnormal bone changes which may interfere with growth.  
- Risk in pre-menopausal women: more likely to develop menopause when taking bevacizumab.  
Reproductive risks: You should not become pregnant or father a baby while on this study and for at least 6 months after because the drugs in this study can affect an unborn baby. If you are a woman of childbearing age, and have not been surgically sterilized (tubal ligation or hysterectomy), you must have a pregnancy test before enrolling in this study. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. If you would like to have children in the future, you should talk to your physician about this. For more information about risks and side effects, ask your study doctor.

Table Version Date: May 23, 2016 COMMON, SOME MAY BE SERIOUS
In 100 people receiving bevacizumab, more than 20 and up to 100 may have:
High blood pressure which may cause headache or blurred vision OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving bevacizumab, from 4 to 20 may have:  
|    | Anemia which may require blood transfusion                                                                                                                                                         |
|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    | Low white cell count that may increase the risk of infection                                                                                                                                       |
|    | Infection, including collection of pus in the belly or rectum                                                                                                                                      |
|    | Abnormal heartbeat which may cause palpitations or fainting                                                                                                                                        |
|    | Pain in the belly, rectum, chest, joints, muscles, or tumor                                                                                                                                        |
|    | Low appetite, constipation, diarrhea, heartburn, nausea, vomiting, or  dehydration                                                                                                                 |
|    | Internal bleeding which may cause black tarry stool, blood in vomit, coughing  up blood, or blood in urine                                                                                         |
|    | Bleeding from other sites, including the vagina or nose                                                                                                                                            |
|    | Blockage of internal organs which may cause vomiting or inability to pass stool                                                                                                                    |
|    | Sores in the mouth                                                                                                                                                                                 |
|    | Allergic reaction during or after infusion of bevacizumab which may cause  fever, chills, rash, itching, hives, low blood pressure, wheezing, shortness of  breath, swelling of the face or throat |
|    | Delay in healing of wounds or spontaneous opening of wounds                                                                                                                                        |
|    | Weight loss, tiredness, or dizziness                                                                                                                                                               |
|    | Muscle weakness                                                                                                                                                                                    |
|    | Damage to organs which may cause loss of teeth or loss of motion                                                                                                                                   |
|    | Headache                                                                                                                                                                                           |
|    | Numbness, tingling or pain in the fingers or toes                                                                                                                                                  |
|    | Hoarseness, stuffy nose, or cough                                                                                                                                                                  |
|    | Dry skin                                                                                                                                                                                           |
|    | Swelling and redness of the skin                                                                                                                                                                   |
|    | Blood clot in limbs or lungs which may cause swelling, pain, shortness of  breath                                                                                                                  |
|    | Leakage of protein in the urine, which can rarely lead to damage to the kidney                                                                                                                     |

In 100 people receiving radiation to the brain, 3 or fewer may have:
Severe local damage to normal brain tissue, a condition called necrosis (tissue deterioration). Radiation necrosis can mimic recurrent brain tumor and may require surgery for diagnosis and treatment.  
Injury to the eyes with the possibility of blindness Development of other tumors (either benign or malignant)

In 100 people receiving bevacizumab, 3 or fewer may have:
Additional Notes on Possible Side Effects for Bevacizumab:
- Risk in children or adolescents: abnormal bone changes which may interfere with growth.  
- Risk in pre-menopausal women: more likely to develop menopause when taking bevacizumab.  
Reproductive risks: You should not become pregnant or father a baby while on this study and for at least 6 months after because the drugs in this study can affect an unborn baby. If you are a woman of childbearing age, and have not been surgically sterilized (tubal ligation or hysterectomy), you must have a pregnancy test before enrolling in this study. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. If you would like to have children in the future, you should talk to your physician about this. 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 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 very small. Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included. The samples are given a code to protect your privacy before they are used. Any related information given to researchers will also be coded. Researchers will receive the code instead of any information that might directly identify you. There can be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a research study. Even though your genes are unique, you share some of the same genes with your blood relatives. Although we are not able to know all of the risks from taking part in research on inherited traits, we believe that the risks to you and your family are very low, because your samples will be coded. Research results will not be returned to you or your doctor. Very rarely health or genetic information could be misused by employers, insurance companies, and others. For example, life insurance companies may charge a higher rate based on this information. Many states have laws to protect against genetic discrimination [list appropriate state information if your state or locality has such laws]. Additionally, a federal law called the Genetic Information Non-Discrimination Act, or GINA, is in effect. This law prohibits health insurer or employer discrimination. The law does not include other types of misuse by life insurance, disability, or long term care insurance. To learn more about the GINA Law, please ask [Note to local investigator: Contact information for patient representatives or other individuals in a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can be listed here.]
Clinical trial: NCT01730950
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study?

Before you begin the study … 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.  
Magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain o An MRI is imaging using a strong magnetic field to look at one part of your body 1 o A CT scan is a study using x-rays to look at one part of your body Laboratory tests for o Blood counts o Kidney function o Liver function o A sample of your urine will be tested History/physical examination Neurologic examination Evaluation of your ability to carry out daily activities Pregnancy test (if you are a woman of child-bearing potential)
Clinical trial: NCT01730950
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

Bevacizumab is a commercially available drug that is FDA approved for the treatment of glioblastoma that has returned after treatment (recurrent glioblastoma). However, treatment with bevacizumab alone has only modestly improved survival in patients with this type of brain tumor. For this reason, researchers are evaluating other treatments, including bevacizumab combined with radiation. The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas.. In this trial patients will be randomly assigned to receive either bevacizumab alone or bevacizumab and radiation therapy.
Clinical trial: NCT01730950
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 Urine 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 Urine Yes  No
3. Someone may contact me in the future to ask me to take part in more research.  
Yes  No
Clinical trial: NCT01730950
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 bevacizumab or radiation plus bevacizumab can be evaluated by your doctor. Another reason to tell your 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.