Clinical trial: NCT01833832
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

| PATIENT IDENTIFICATION   | CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent   |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|  
STUDY NUMBER: 13-C-0114 CONTINUATION: page 7 of 10 pages Instead of being in this study, you have these options:
- Getting treatment or care for your cancer without being in a study  
- Taking part in another study
- Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT01833832
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

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. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
- The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Cancer Institute Institutional Review Board  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 13-C-0114 CONTINUATION: page 8 of 10 pages 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.
Clinical trial: NCT01833832
Section: Duration of Study Involvement
Subsections: Recovery|Follow Up

After the operation you will be admitted to the Intensive Care Unit (ICU) where you will be monitored closely for 1-4 days. As with any major operation, you may have a breathing tube and be connected to a breathing machine for 1-2 days following the operation. You will have a tube in your stomach, a catheter (tube) in your bladder and several IVs during this period. As soon as you are able, you will be helped to get out of bed, to cough and take deep breaths and to walk. Once your bowel function has returned to normal, you will be allowed to eat - this usually takes 5-7 days. When your condition is stable, you will be transferred to the regular patient care unit until you are ready to be discharged to home, usually 7-14 days following the operation. Throughout your hospitalization, you will receive pain medications, IV fluids, antibiotics, and blood transfusions as necessary.

You will be asked to return to the NIH Clinical Center for follow up examinations every few weeks until you have fully recovered from the operation and HIPEC. After that, you will be seen about every 3 months for the first year; every four months for the next year and then every six months thereafter. If you are not able to come to the NIH Clinical Center, we will contact you by phone or e-mail and may ask that you send copies of your scans, lab works and physician notes to us.
Clinical trial: NCT01833832
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT01833832
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

What side effects or risks can I expect **from being in this study?** The operation to remove the tumors throughout your abdomen is likely to be quite extensive and will incorporate HIPEC as well. The risks from this operation, HIPEC and general anesthesia include:

The aim of this study is to see if this experimental treatment will prevent your tumors from growing back. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the treatment's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT01833832
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Study:|Surgery To Remove All Of Your Tumors:|Hipec

You will have several tests performed to be certain it is safe for you to have the operation and the HIPEC. This may include blood tests, CT and MRI scans, pulmonary and heart function tests; you may also have consultations with a cardiologist and an anesthesiologist.

Once you have completed all of the testing and your physician has reviewed the results to determine that this procedure is safe for you, you will be admitted to the hospital. Most patients are admitted 1-2 days before their operation. Your physician will explain the surgical procedure and HIPEC and will answer any questions you may have. You will be asked to sign a separate consent for the operation. In order to remove all of the tumors in your abdomen, you will need to have a major operation. This will include removing the tumors as well as parts of any organs that the tumors may be attached to (for example liver, intestines.) If you have tumors in your peritoneum (the thin film of tissue that covers all of your abdominal organs) this will be removed. After we have removed all of the tumors that we can see, you will undergo HIPEC while you are in the operating room. If your surgeon cannot remove the majority of your tumors or if the surgeon considers it unsafe you will not receive the HIPEC.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 13-C-0114 CONTINUATION: page 4 of 10 pages

Two catheters (or thin tubes) will be put in your abdomen. The cisplatin will be diluted in a heated solution and will be given to you through one catheter in your abdomen and drained out through another, bathing the inside of your abdomen with cisplatin. This chemotherapy solution will be washed through your abdomen over 90 minutes at a temperature of about 104 - 105 degrees, which is above your normal body temperature. After your abdomen has been bathed for 90 minutes, the chemotherapy will be rinsed out and the catheters will be removed. During this procedure we will carefully monitor your temperature. If your body temperature goes up during the procedure, we will use cooling blankets and ice packs to keep your body temperature normal.  
In order to reduce the risk of side effects (especially kidney damage), from any of the cisplatin that may leak into your bloodstream while it is in your abdomen, a second medicine called sodium thiosulfate will be given to you through your vein during the HIPEC treatment. Sodium thiosulfate binds to cisplatin in the blood and makes it less harmful.
Clinical trial: NCT01833832
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

Adrenocortical carcinoma (ACC) is a rare tumor that has a very poor prognosis; few patients diagnosed with this disease live beyond 5 years after being diagnosed. Those whose tumors have spread throughout their abdomen have an especially poor prognosis and traditional chemotherapy is not very effective. At the NIH Clinical Center, we have treated patients with other types of cancer whose tumors have spread throughout their abdomen with aggressive surgical removal of their tumors followed by heated  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH **STUDY**  
- Adult Patient or - Parent, for Minor Patient  
NIH-2514-1 (07-09) P.A.: 09-25-0099 File in Section 4: Protocol Consent (1)  
STUDY NUMBER: 13-C-0114 CONTINUATION: page 2 of 10 pages chemotherapy with good results. We think that this type of treatment may help patients with ACC. In this study, we would like to determine if this type of surgery plus heated chemotherapy can improve survival in patients with ACC.

You are being asked to take part in this study because you have been diagnosed with ACC and although your tumor has spread throughout your abdomen, we think that we will be able to remove most of the tumors with an operation. Standard chemotherapy usually does not prevent tumors like yours from growing following surgery but we think that giving heated chemotherapy directly into your abdomen may prevent or increase the length of time that it takes for the tumors to grow back.
Clinical trial: NCT01833832
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
- if he/she believes that it is in your best interest  
- if you have side effects from the treatment that your doctor thinks are too severe
In this case, you will be informed of the reason therapy is being stopped.  
You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.