Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
Pancreatic Cancer | Resectable Pancreatic Adenocarcinoma | Pancreatic Adenosquamous CarcinomaThis phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
PRE-REGISTRATION:
* Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma
* TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)
* Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance imaging (MRI) scan and 2) chest CT:
* No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
* Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
* No evidence of metastatic disease
* Measurable disease or non-measurable disease o Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging
REGISTRATION:
* Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio
* Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection
* No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Total Neuropathy Score \< 2
* Absolute neutrophil count (ANC) \>= 1,500/uL
* Platelet count \>= 100,000/uL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin =\< 3.0)
* Creatinine =\< 1.5 x ULN OR calculated (Calc.) creatinine clearance \>= 30 mL/min (Calculated using the Cockcroft-Gault equation)
* No known Gilbert's Syndrome or known homozygosity for UGAT1A1\*28 polymorphism
* No comorbid conditions that would prohibit curative-intent pancreatectomy
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration
* Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration
Lieu de l'étude
BCCA-Vancouver Cancer Centre
BCCA-Vancouver Cancer CentreVancouver, British Columbia
Canada
Contactez l'équipe d'étude
Site Public Contact
888-939-3333Daniel J. Renouf
Juravinski Cancer Centre at Hamilton Health Sciences
Juravinski Cancer Centre at Hamilton Health SciencesHamilton, Ontario
Canada
Contactez l'équipe d'étude
Site Public Contact
905-387-9495Pablo E. Serrano
The Research Institute of the McGill University Health Centre (MUHC)
The Research Institute of the McGill University Health Centre (MUHC)Montreal, Quebec
Canada
Contactez l'équipe d'étude
George Zogopoulos
Tom Baker Cancer Centre
Tom Baker Cancer CentreCalgary, Alberta
Canada
Contactez l'équipe d'étude
Patricia Tang
Site Public Contact
403-521-3433QEII Health Sciences Centre/Nova Scotia Health Authority
QEII Health Sciences Centre/Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
Contactez l'équipe d'étude
Ravi A. Ramjeesingh
Site Public Contact
902-473-6000Odette Cancer Centre- Sunnybrook Health Sciences Centre
Odette Cancer Centre- Sunnybrook Health Sciences CentreToronto, Ontario
Canada
Contactez l'équipe d'étude
Michael J. Raphael
Site Public Contact
416-480-5000BCCA-Vancouver Island Cancer Centre
BCCA-Vancouver Island Cancer CentreVictoria, British Columbia
Canada
Contactez l'équipe d'étude
Nicholas A. Bosma
Site Public Contact
604-877-6010Kingston Health Sciences Centre
Kingston Health Sciences CentreKingston, Ontario
Canada
Contactez l'équipe d'étude
Sean Bennett
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)Quebec City, Quebec
Canada
Contactez l'équipe d'étude
Jean-Francois Ouellet
CancerCare Manitoba
CancerCare ManitobaWinnipeg, Manitoba
Canada
Contactez l'équipe d'étude
Christina Kim
Ottawa Hospital and Cancer Center-General Campus
Ottawa Hospital and Cancer Center-General CampusOttawa, Ontario
Canada
Contactez l'équipe d'étude
Site Public Contact
613-761-4395Guillaume Martel
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrooke, Quebec
Canada
Contactez l'équipe d'étude
Frederic Lemay
- Étude parrainée par
- Alliance for Clinical Trials in Oncology
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT04340141