Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cancer of Pancreas, Chemotherapy Effect, Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: Gemcitabine fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>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 | Drug: Gemcitabine fluorouracil<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | describes according to RECIST criteria | 6 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) | Describes according to CTCAE | 6 months from chemotherapy | 
| Progression free survival (PFS) | The time interval between the date of metastasis to the date of next disease progression | One year from start of enrollment | 
| Overall survival (OS) | The time interval between the date of diagnosis till the date of death | One year from start of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas, cancer, adenocarcinoma, metastatic, gemcitabine, flourouracil, chemotherapy, first line