Clinical trial NCT04769414: Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)
Official title: A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of Pancreas
Chemotherapy Effect
Metastatic Pancreatic Cancer
Keywords: pancreas
cancer
adenocarcinoma
metastatic
gemcitabine
flourouracil
chemotherapy
first line
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 6 months from enrollment
Secondary outcomes:
measure: Adverse events (AE)
timeFrame: 6 months from chemotherapy
measure: Progression free survival (PFS)
timeFrame: One year from start of enrollment
measure: Overall survival (OS)
timeFrame: One year from start of enrollment
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University, Faculty of medicine
state: Menoufia
Study officials:
References:
citation: 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.