Clinical Trials

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STUDY NAME: Study of Low-Dose Radiation Therapy to the Whole Liver in Combination with Gemcitabine and Cisplatin in Intrahepatic Cholangiocarcinoma

ClinicalTrials.gov Identifier: NCT02254681

STUDY CENTER

Virginia Piper Cancer Institute

800 East 28th Street, Suite 602

Minneapolis, MN 55407

Phone: 612-863-7553

STUDY CONTACTS

Principal Investigator: Srinevas K. Reddy, MD

PI Phone: 612-863-7553

PI E-Mail: srinevas.reddy@allina.com

Study Coordinator: Laura Rockwell, RN

Study Coordinator Phone: 612-863-9466

Study Coordinator E-mail: laura.rockwell@allina.com

OVERVIEW

In this Phase II study, researchers want to determine whether lower dose radiation therapy improves the response derived from chemotherapy for intrahepatic cholangiocarcinoma by combining chemotherapy treatment with low dose radiation therapy to the entire liver and adjacent lymph nodes.  Patients with surgically treatable or untreatable disease, and those with disease confined to or outside the liver are eligible for this study. Patients will have 4 cycles of treatment with each cycle lasting 3 weeks. All patients receive the same treatment. Medical history, physical examination and bloodwork are required.

Enrollment: 45 patients

Study Start Date: 9/25/2014

Estimated Study Completion Date: 01/30/2020

PURPOSE OF THE STUDY

  1. Determine if the combination of low-dose radiation and chemotherapy results in a better treatment response and longer duration of response compared to that observed with chemotherapy alone
  2. Determine if the safety of combined low-dose radiation therapy and chemotherapy treatment is substantially different from that of chemotherapy alone
  3. Determine if low-dose radiotherapy alters the safety of liver surgery for those patients who are candidates for surgery after combined low-dose radiation therapy and chemotherapy treatment

INCLUSION CRITERIA – Patients must:

  1. Have satisfactory heart, lung, and kidney functions to tolerate chemotherapy treatment, and
  2. Have satisfactory blood test results, and
  3. Be either fully active or able to walk with assistance

EXCLUSION CRITERIA – Patients must:

  • NOT have had prior chemotherapy, surgery, or radiation for intrahepatic cholangiocarcinoma
  • NOT have had prior or current diagnoses of cirrhosis, primary sclerosing cholangitis hepatitis viral infections
  • NOT be pregnant or unwilling to use adequate contraception (women)

REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT

  • MRI of the abdomen
  • CT scan of the chest
  • Basic laboratory work

POTENTIAL SIDE-EFFECTS

  • Gemcitabine: Flu-like symptoms such as fever, fatigue, muscle aches, headache, cough, and mild nausea/vomiting are common. If a decrease in blood counts occur—the dose of chemotherapy will be adjusted in these cases.
  • Cisplatin: Flu-like symptoms such as fever, fatigue, muscle aches, headache, cough, and mild nausea/vomiting are common. A decrease in kidney function may occur—giving fluids and reducing in the dose of chemotherapy usually corrects this problem.
  • Radiation: Injury to surrounding structures such as stomach, small intestine, kidney, and spinal cord is possible. However, due to precise direction of the radiation combined with the very low doses used in this study, the likelihood of these side effects are low.

PLEASE DOWNLOAD, PRINT AND CONSULT WITH TREATING PHYSICIAN

A list of current clinical trials from the National Cancer Institute.

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Video: Participating in a Clinical Trial

This eight minute video features the stories of two clinical research volunteers who provide a personal perspective into the clinical research process.  Also in the video are interviews with their family members who offer insight into what it’s like when a loved one is undergoing experimental treatment.

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Smart Talking about Clinical Studies

This engaging webpage is designed to provide a brief introduction to clinical trials with interactive videos that provide patients with important information about taking part in a clinical trial.  You will also find useful information about clinical trials in general and a glossary with definitions of research phrases and terms.

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Why They Chose to be Research Volunteers

This video shares the stories of several trial participants including their perspectives and the motivations behind their decision to take part in clinical research.

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Clinical Trials 101

In 2010, Dr. Jack Welch from the National Cancer Institute (NCI), joined gave a presentation to the Cholangiocarcinoma Foundation and our community, the purpose of his webinar was to discuss some clinical trial basics and to answer some frequently asked questions.