A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pan… (NCT01660711) | Clinical Trial Compass
CompletedPhase 2
A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma
United States22 participantsStarted 2012-07
Plain-language summary
The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.
* Resectable primary tumor of the head, body or tail of the pancreas defined as a visible mass in the pancreas and:
* No extrapancreatic disease
* A patent superior mesenteric (SMV)- portal vein (PV) confluence (assuming the technical ability to resect and reconstruct this venous confluence if needed)
* A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.
* Confirmation of resectability by surgical oncology consultation.
* Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University
* No previous therapy for pancreatic cancer
* Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice
* Karnofsky performance status 80 or better
* Age \> 21 years
* No currently active second malignancy
* No CVA within 6 months, no MI within 6 months
* The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregna…
What they're measuring
1
Percentage Able to Complete Full Course of Preoperative Chemotherapy
Timeframe: Following completion of all planned therapy, an expected average of 4 months