Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients Wi… (NCT02676349) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)
France130 participantsStarted 2016-10-13
Plain-language summary
This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* ECOG performance status 0 or 1
* Adult patients ≥ 18 years and ≤ 75 years of age
* Histologic or cytologic proven adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred)
* Confirmation by independent multidisciplinary expert review of borderline resectable status, according to NCCN-Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma", version 1.2015.
* Adequate hematologic function, as follows:
* absolute neutrophil count (ANC) ≥ \> 2000/mm3
* platelet count ≥ 100 000/mm3
* haemoglobin ≥ 10 g/dL
* Adequate renal, hepatic and bone marrow function, defined as:
* Calculated creatinine clearance ≥ 50 mL/min according to MDRD formula
* Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. Patients with a biliary short metal stent due to cancer obstruction may be included provided that high-quality imaging is performed before stenting and bilirubin level after stent insertion decreased to ≤ 20 mg/L (≤ 34 µmol/l), and there is no cholangitis.
* Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, combined oral contraceptives, some intrauterine devices \[IUDs\], sexual abstinence, or sterilized partner)
* for male subject: during the treatment and for up to 6 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.
* for female subject: during the treatment and for up to 4 months after the last dose of oxa…
What they're measuring
1
To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate