About the TIGeR-PaC Trial
The TIGeR-PaC Study is investigating a new way of administering anti-cancer drugs (chemotherapy) in people with pancreatic cancer that cannot be treated surgically and has not spread to other parts of the body.
The TIGeR-PaC Study is enrolling people who have recently been diagnosed with pancreatic cancer that cannot be treated surgically and has not spread to other parts of the body. The goal is to determine whether an investigational method of delivering a routine anticancer drug, known as chemotherapy, with a device called RenovoCath®, can reduce the chance of the cancer spreading and extend survival, while improving quality of life.
Unlike other treatments that are given intravenously or into a vein (known as systemic chemotherapy), with RenovoCath the drug is delivered directly into the pancreas via an artery. This is known as intra-arterial administration and involves the placement of a thin tube (called a catheter) into the artery via a small incision made in the leg or groin. There is evidence that delivering chemotherapy via an artery close to the tumor is an effective method for shrinking or stabilizing certain types of cancer. Studies have shown that gemcitabine delivered directly to the pancreatic arteries using RenovoCath may be associated with more than half the patients living over two years.
The study will randomize approximately 200 participants in 40 study centers across the United States and Europe.
Candidates for the TIGeR-PaC Study must:
- have a diagnosis of locally advanced pancreatic cancer that has not spread to other parts of the body;
- have a life expectancy > 12 weeks;
- not have received prior treatment for pancreatic cancer;
- not be a candidate for surgery. There are other checks to complete before you can join the study. Your doctor will discuss these with you to determine whether you are right for the study, and the study is right for you.
Expectations of Treatment Protocol
TIGeR-PaC Study participants can expect to:
- be given either intra-arterial chemotherapy delivered via RenovoCath or intravenous systemic chemotherapy;
- the total number of treatments you receive, and how long you remain in the study, will depend on how well you respond to treatment;
- have regular medical tests under expert care from the study doctor and team;
- have some specific tests to evaluate how well the chemotherapy is working.
If you qualify for the study, study medicine and all study-related care will be provided at no additional cost by your insurance or Company conducting the TIGeR-PaC Study. Participation in the TIGeR-PaC Study is voluntary and you can leave the study at any time, for any reason.