Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN)

In this study, the investigators designed a treatment regimen including the most active agents in pancreatic cancer which are gemcitabine and fluorouracil to be tested as a first line treatment. This regimen is expected to be less toxic than FOLFIRINOX and aiming at better outcomes.

Metastatic cancer pancreas has been a challenge for oncologists over the years. It is a disease of limited survival and a very poor response to treatment. The median overall survival at five years is expected to be between 4-6% only. Adenocarcinoma is the most common type of pancreatic cancer. It is the tenth most common adult solid malignancy. Most of the new therapeutic modalities has proven to be non-beneficial in this disease including targeted and immunotherapy. For many years, the first line of treatment for pancreatic cancer was gemcitabine either alone or in combinations. Recently, FOLFIRINOX has become the standard of care due to its overall survival benefit. However, it is a small benefit on the expense of great toxicity. Patients with metastatic cancer pancreas are recruited to receive the test regimen. Baseline evaluation will be done either by CT scan or PET/CT. re-evaluation will be repeated after 3 months of treatment and at end of 6 months

Participants will receive the test protocol Gem-5FU on biweekly basis for 6 months with interim evaluation Doses as follows: Gemcitabine 1000 mg/m2, infusion over 30 min, D1, D15 Leucovorin 400 mg/m2 infusion over 30 min , D1, D15 5FU 400 mg/m2 I.V. shot D1, D15 5FU 2000 mg/m2 infusion over 46 hours D1 , D15

chemotherapy protocol given as: Gemcitabine 1000mg/m2 IV short infusion Leucovorin 400 mg/m2 IV short infusion Flourouracil 400 mg/m2 direct IV shot Flourouracil 2000 mg/m2 contineous infusion over 46 hours The whole regimen will be repeated bi-weekly

Inclusion Criteria: Histopathological evidence of adenocarcinoma of the pancreas Radiological proof of metastatic disease as defined by AJCC Exclusion Criteria: patients with poor performance status (ECOG 4) patients with organ dysfunction defined as: creatinine more than 1.6 mg/dl or bilirubin more than 3 mg/dl patients with end stage renal disease who are under regular dialysis other histologies of pancreatic cancer irresectable pancreatic cancer if not metatatic

IPD can be shared with other investigators upon personal contact with the PI of the study and after publishing the primary results. The investigators of this study are to be submitted as co-investigators in any other studies using the data of this study.

Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.