Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769414
• Other study ID #: 352
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2021
• Est. completion date: July 9, 2022

Study information

• Verified date: August 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 9, 2022
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer of Pancreas
• Chemotherapy Effect
• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Menoufia University, Faculty of medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	describes according to RECIST criteria	6 months from enrollment
Secondary	Adverse events (AE)	Describes according to CTCAE	6 months from chemotherapy
Secondary	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
Secondary	Overall survival (OS)	The time interval between the date of diagnosis till the date of death	One year from start of enrollment