Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, 32511, Egypt
NCT Number: NCT04769414
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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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Shibīn al Kawm, Menoufia, 32511, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
chemotherapy protocol given as:
The whole regimen will be repeated bi-weekly
Time frame: 6 months from enrollment
describes according to RECIST criteria
Time frame: 6 months from chemotherapy
Describes according to CTCAE
Time frame: One year from start of enrollment
The time interval between the date of metastasis to the date of next disease progression
Time frame: One year from start of enrollment
The time interval between the date of diagnosis till the date of death
Menoufia University
Other
A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN)
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