Houston, Texas 77030


Purpose:

The goal of this study is to learn if computed tomography (CT) scans can help researchers predict how patients with pancreatic cancer may respond to chemotherapy. This is an investigational study. The CT scans are performed using FDA-approved and commercially available methods. Up to 259 patients will take part in this study. All will be enrolled at MD Anderson.


Study summary:

If you agree to take part in this study, 2 CT scans that are part of your regular cancer care will be reviewed for biomarkers. Biomarkers can be seen in CT images and may be related to the status of the disease. One (1) scan will be performed before you start chemotherapy, and the other will be at your first restaging visit with your oncologist. You will also be asked to complete 1 questionnaire, the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) , to check on your health status. This questionnaire will take about 10 minutes to complete. This may be done within one week of your scheduled visits, in person or by telephone. The study staff will also collect information from your medical record. Length of Study: Your active participation on the study will be over after your last CT scan. Follow-Up: After your last CT scan, you will have follow-up visits and/or calls. During these visits and/or calls, you will be asked to complete 1 questionnaire, the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) , to check on your health status. This questionnaire will take about 10 minutes to complete. If you are planning to have clinic visits at MD Anderson after chemotherapy as part of your regular cancer care, a member of the study staff will meet with you briefly during those visits to check on your health status. If you are not coming to MD Anderson for your follow-up care, a member of the study staff will call you every 3-4 months to see how you are doing. These calls should last about 10 minutes.


Criteria:

Inclusion criteria for pancreatic cancer: 1. Histologically confirmed adenocarcinoma of the pancreas 2. Age 18 or older 3. non-distant metastatic pancreatic cancer that is either 1. unresectable locally advanced disease, defined as primary tumor that involves >180 degrees of the superior mesenteric artery, celiac axis or any of its branches on CT or MRI, primary tumor that occludes the superior mesenteric vein or portal vein, aorta or inferior vena cava invasion, or superior mesenteric vein invasion below the transverse mesocolon 2. borderline resectable disease, defined as primary tumor that involves </=180 degrees of the superior mesenteric artery, celiac axis or any of its branches on CT or MRI, primary tumor that involves the superior mesenteric vein causing vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction, or primary tumor that abuts or encases (>/=50% of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin) 4. ECOG PS 0-1 5. Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding. 6. Patient who has been recommended chemotherapy treatment for pancreatic cancer 7. Signed study-specific consent form Inclusion criteria for hepatobiliary cancers: 1. Diagnosis of a. Hepatocellular carcinoma: This may be diagnosed in the following ways: i. Pathologically (histologically or cytologically) proven diagnosis of HCC. ii. At least one solid liver lesion with arterial enhancement and washout on a delayed phase of a multi-phasic CT or MRI in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis. b. Intrahepatic cholangiocarcinoma: Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma 2. Patients may have single or multinodular tumors 3. Age 18 or older 4. ECOG PS 0-1 5. Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception. 6. Prior history of surgical resection, chemotherapy, TACE, and/or radiofrequency ablation are allowed. 7. Patients may be enrolled if: 1. The patient is dispositioned to receive definitive radiotherapy 2. The patient has received definitive radiotherapy within the past two years and has liver protocol CT or MRI scans before radiotherapy and at first restaging after radiotherapy 8. Signed study-specific consent form Exclusion criteria: 1. Presence of distant metastasis 2. Patients whose tumors are defined as resectable 3. Unstable angina or New York Heart Association Grade II or greater congestive heart failure 4. Evidence of fever or acute infection (chronic infection such as Hepatitis virus is acceptable) 5. Coexisting medical condition that would preclude chemotherapy, radiotherapy, or iodine-based contrast enhanced CT scan 6. Pregnant women with a positive pregnancy test 7. Inability to comply with study and/or follow-up procedures 8. Patients younger than 18 years of age 9. Patients with an active second malignancy with the exception of non-melanoma skin cancer


NCT ID:

NCT02361320


Primary Contact:

Principal Investigator
Eugene J. Koay, MD,PHD
M.D. Anderson Cancer Center

Eugene J. Koay, MD, PHD
Phone: 713-563-2300


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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