Clinical trial: NCT03223662
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

Instead of being in this study, you have these options:  
- Getting treatment or care for your esophageal cancer at a different facility without being in a study
- Taking part in another study that you are eligible for. - 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: NCT03223662
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept **Private?**|Certificate Of Confidentiality

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.  
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: 17-C-0135 CONTINUATION: page 8 of 11 pages  
- National Cancer Institute Institutional Review Board
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.

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:
- will be used for auditing or program evaluation internally by the NIH; or  
- must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
- is necessary for your medical treatment and you have consented to this disclosure;
- is for other research.
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT03223662
Section: Duration of Study Involvement
Subsections: During The **Study**

First, you will undergo a baseline evaluation (if these tests were already performed at screening, we probably will not need to repeat them):
- History, physical examination and assessment of your activity level  
- EGD (Esophagogastroduodenoscopy - is a procedure to examine the esophagus, stomach and first portion of the small intestine: lighted tube will be inserted into your mouth and go down to the small intestine). Biopsies of tumor and normal tissue will be taken for research studies o The biopsy by endoscopy by our team is the critical step to obtain tissue. This biopsy is necessary for the study, as it is important for deciding the best operation for you. After this endoscopy, you will usually return to your referring doctors for standard chemotherapy and radiation. After that treatment, you will return to the NIH for esophagectomy. Given that you will often be treated by us at the NIH and your home doctor, we do ask that you enroll on another study that allows us to treat you.  
- PET/CT scan
- Routine blood tests
- Pregnancy test
- Nutritional assessment
- Research blood and urine tests
- PFT (pulmonary test) if medically indicated  
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: 17-C-0135 CONTINUATION: page 3 of 11 pages
- EUS (Endoscopic ultrasound) if medically indicated.  
After that you will have neoadjuvant chemoradiotherapy here at NIH Clinical Center or with your local physician. After chemoradiotherapy you must return to the NIH Clinical Center for surgery and recovery. During surgery, we will take tumor and normal tissue biopsies for research studies. You will have blood and urine collected for research on Day 7 after surgery. You will undergo a robotically-assisted, minimally-invasive esophagectomy (RAMIE) if feasible at the NCI in which the operation is performed with cameras and scopes. For those whom a scope procedure is contraindicated or for institutions that do not perform these procedures, a traditional open approach will be performed with incisions in the abdomen, chest, and neck. The surgical approach depends on tumor location. The approach will be different for adenocarcinoma versus squamous cell carcinoma. Most adenocarcinoma are located in the lower esophagus near the stomach which requires an abdominal incision with either a chest or neck incision. In contrast, most squamous cell carcinomas are in the middle of the esophagus and require an incision in the chest followed by an incision in both the abdomen and neck. With both operations, most of the esophagus and top of the stomach are removed. The remainder of the stomach is pulled into the chest and connected to the remaining esophagus. Feeding tubes are placed in all patients at the NCI. Feeding by the tube will be started a few days after the operation until you are eating enough to maintain enough calories which typically takes 10-14 days. Feeding tubes are continued after discharge for a variable length of time depending on your nutritional needs. Following the surgery, we will invite you every 3 month during the first year, every 6 months during the second year and yearly after that for post-operative evaluation and research tests:
- PET/CT scan  
- Routine blood tests
- Nutritional assessment
- Research blood and urine tests
Clinical trial: NCT03223662
Section: Participant's Rights
Subsections: Will My Genetic Information Be Shared With Me?|Research Subject'S Rights What Are The Costs Of Taking Part In This **Study?**

The genetic analyses performed in various laboratories under this protocol are for research purposes only and they are not as sensitive as the tests that are performed in a laboratory that is certified to perform genetic testing for clinical purposes (CLIA certification). Observed changes may or may not be valid. Therefore, we do not plan to inform you of the results of testing on the tissue and blood that is performed in our research lab. However, in the unlikely event that clinically relevant incidental findings are discovered, you will be contacted. In this case, we will ask you to provide additional blood sample to be sent to a CLIA certified laboratory. If the research findings are verified in the CLIA certified lab, you will be referred to an NCI CCR Genetics Branch certified genetic health care provider for the disclosure of the results. This is the only time during the study when incidental findings will be returned to you.

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: NCT03223662
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Research Procedure **Risks** Blood Draw|Privacy Risks Related To The Release Of Genetic Information:

Side effects of blood draws include pain and bruising in the area where the needle was placed, lightheadedness, and rarely, fainting. When large amounts of blood are collected, low red blood cell count (anemia) can develop.

- Your privacy is very important to us and we will use many safety measures to protect your privacy. However, despite all the safety measures that we will use, we cannot guarantee that your identity will never become known. Although your genetic information is unique to you, you do share some genetic information with your children, parents, brothers, sisters, and other blood relatives. Consequently, it may be possible that genetic information from them could be used to help identify you. Similarly, it may be possible that genetic information from you could be used to help identify them.  
- While the controlled-access databases developed for this project will not contain information that is traditionally used to identify you, such as your name, address, telephone number, or social security number, people may develop ways in the future that would allow someone to link your genetic or medical information in our databases back to you. For example, someone could compare information in our databases with information from you (or a blood relative) in another database and be able to identify you (or your blood relative). It also is possible that there could be violations to the security of the computer systems used to store the codes linking your genetic and medical information to you.  
- Since some genetic variations can help to predict the future health problems of you and your relatives, this information might be of interest to health providers, life insurance companies, and others. Patterns of genetic variation also can be used by law enforcement agencies to identify a person or his/her blood relatives. Therefore, your genetic information potentially could be used in ways that could cause you or your family distress, such as by revealing that you (or a blood relative) carry a genetic disease.  
- There also may be other privacy risks that we have not foreseen.
There are state and federal laws that protect against genetic discrimination. There is also a federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers to STUDY NUMBER: 17-C-0135 CONTINUATION: page 6 of 11 pages discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not apply to members of the United States military, to veterans obtaining health care through the Veteran's Administration or the Indian Health Service. Lastly, GINA does not forbid insurance medical underwriting based on your current health status.
Clinical trial: NCT03223662
Section: Procedures
Subsections: Surgical Procedure

An esophagectomy carries significant post-surgical complications. The main risks that are life threatening are heart attacks and blood clots. Both conditions are rare. The risk of heart attack is evaluated by assessing your heart before the operation with standard tests. The risk of blood clots is reduced with use of blood thinners and by walking after the operation. The next most serious complications are pneumonia and leak of the connection between the esophagus and the stomach. Pneumonia is an infection of the lungs that is treated with antibiotics. It ranges from  
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: 17-C-0135 CONTINUATION: page 5 of 11 pages serious to minor but will be monitored closely. Occasionally, the breathing machine is necessary to recover from pneumonia. A leak requires intervention to fix. Usually, we will perform an endoscopy and place a stent to let the leak heal. Occasionally, we have to operate to fix it. Loss of the stomach connected to the esophagus is very rare, but if it occurs, re-operation is necessary. Multiple additional complication can occur but usually are managed without significant problems. Infections in the incisions are drained or treated with antibiotics. Bladder or urine infections are treated with antibiotics. Abnormal heart rhythms are common and usually managed with medications. Blood clots in the legs are usually managed with stronger blood thinners.
Clinical trial: NCT03223662
Section: Purpose of Research
Subsections: Description Of Research Study Before You Begin The **Study**

Before you enroll in the study you will need to have the following exams and tests to make sure you are eligible for this study: standard lab tests, imaging studies, and a physical exam to be sure that it would be safe for you to proceed with chemoradiotherapy followed by surgery. You will be asked to provide a confirmation of your diagnosis. If a pathology report or tumor sample from a previous surgery/biopsy is not available, you will need to have a biopsy of your tumor. If you are a woman who can have children, pregnancy test will be done, because pregnant women cannot participate in the study.
Clinical trial: NCT03223662
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  
| 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: 17-C-0135 CONTINUATION: page 7 of 11 pages  
- If surgery is no longer appropriate because your cancer spread to other parts of the body or you are not able to safely undergo an operation.  
- if new information shows that another treatment would be better for you
- if you become pregnant
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. 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.