Cancer of Pancreas, Chemotherapy Effect, Metastatic Pancreatic Cancer
Conditions
Keywords
pancreas, cancer, adenocarcinoma, metastatic, gemcitabine, flourouracil, chemotherapy, first line
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.
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
Interventions
DRUGGemcitabine 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
Sponsors
Menoufia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 6 months from enrollment | describes according to RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed