Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-20

Study Completion Date

2022-07-09

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.

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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

Conditions

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Cancer of Pancreas Chemotherapy Effect Metastatic Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy

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

Group Type EXPERIMENTAL

Gemcitabine fluorouracil

Intervention Type DRUG

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

Interventions

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Gemcitabine fluorouracil

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No