Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Menoufia University48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer of Pancreas Chemotherapy Effect Metastatic Pancreatic Cancer

Interventions

Gemcitabine fluorouracilDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, Egypt

Outcomes

Primary Outcomes

Overall response rate (ORR)

describes according to RECIST criteria

Time frame: 6 months from enrollment

Secondary Outcomes

Adverse events (AE)

Describes according to CTCAE

Time frame: 6 months from chemotherapy

Progression free survival (PFS)

The time interval between the date of metastasis to the date of next disease progression

Time frame: One year from start of enrollment

Overall survival (OS)

The time interval between the date of diagnosis till the date of death

Time frame: One year from start of enrollment

Data from ClinicalTrials.gov

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