Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Sponsor

Menoufia University (Other)

Overall Status

Completed

CT.gov ID

NCT04769414

Collaborator

(none)

Enrollment

Location

Arm

16.6

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Pancreas Chemotherapy Effect Metastatic Pancreatic Cancer	Drug: Gemcitabine fluorouracil	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 20, 2021

Actual Primary Completion Date :

Jul 9, 2022

Actual Study Completion Date :

Jul 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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

Arm

Intervention/Treatment

Experimental: 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

Drug: 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

Outcome Measures

Primary Outcome Measures

Overall response rate (ORR) [6 months from enrollment]
describes according to RECIST criteria

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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