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Phase II Study of Folfirinox for Advanced Pancreatic Cancer

Conditions

Advanced Pancreatic Cancer | Metastatic Pancreatic Cancer | Pancreas | Pancreatic Cancer

What is the purpose of this trial?

You are free to choose not to participate and if you do become a subject you are free to withdraw from this study at any time during its course. If you choose not to participate or if you withdraw it will not harm your relationship with your own doctors or with Yale-New Haven Hospital. We would still treat you with standard therapy. Before you make your decision, a member of the research team will be available so that you can ask any questions you have about the research project. You can ask for any information you want. Sign the consent form only after you have had a chance to ask your questions and have received satisfactory answers. If you decide to withdraw from this project, please notify a member of the research team before you withdraw. This notice will allow that person or the research supervisor to inform you if there are any health risks or special requirements linked to withdrawing. The researchers may withdraw you from participating in the research if necessary. This may take place for the following reasons: if the researchers determine that you are having too many side effects from the treatment that it is not longer safe for you or if they feel that being on this study is in any way bad for your health; if your disease grows/spreads while receiving the treatment; if you are unable to comply with the study guidelines for treatment and follow-up; or if the study is being stopped.

The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX). Secondary endpoints include: determine objective response rate according to RECIST; determine overall survival; evaluate toxicity; determine rate of resection in locally advanced unresectable stratum; correlate time to progression, objective response, and overall survival with early changes in glucose metabolism using [18F]-fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Yale Cancer Center
Yale University
Dates:
11/16/2012
Last Updated:
Study HIC#:
1108008901