Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: Gemcitabine with Nab-paclitaxel or FOLFIRI: Gemcitabine 1000 mg/m2 plus
Nab-paclitaxel 125 mg/m2
Patients will be on supportive care and reviewed periodically every 2 cycles as per stud
Sponsors
Tata Memorial Hospital
Extramural Funding will be applied from Pharma Company
Eligibility
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas/ ampulla.Either locally advanced (unresectable)/ Metastatic disease.Documented disease progression or recurrence within 6 months of prior gemcitabine-based thrapy or FOLFIRINOX-based therapy.Age 18 years and above.ECOG performance status 0 – 2.Patients who can give informed consent for the study.The patient does not have any contraindications to receive chemotherapy drugs (Gemcitabine/ Nab-paclitaxel/ Fluorouracil/ irinotecan).Adequate Haematological, hepatic, and renal function parameters.Haematological- Hb > 80 g/L, ANC = 1.5 x 109/L, platelets = 100 x 109/L.Liver functions- bilirubin = 2 x upper limit normal (ULN), AST/ALT = 5 x ULN, S. albumin = 28 g/L.Renal function- Creatinine = 1.5 ULN, Creatinine clearance = 40 mL/min.Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.A life expectancy of at least 12 weeks.
Exclusion criteria
Exclusion criteria: Active CNS metastasis.Recent MI, NYHA Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled blood pressure.Active infection or uncontrolled fever.Pregnant or breast-feeding patients.Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to estimate the efficacy of doublet vs monotherapy as second-line therapy in advanced pancreatic cancers in terms of Progression-free survival (PFS).Timepoint: The primary endpoint is to estimate the efficacy of doublet vs monotherapy as second-line therapy in advanced pancreatic cancers in terms of Progression-free survival (PFS). Estiamte at Baseline and after every 8 Weeks and 8-12 Weeks Chemotherapy in either arm will be continued till disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the efficacy of the doublet vs monotherapy as second-line therapy in advanced pancreatic cancers in terms of overall response rate (ORR).To estimate the efficacy of the doublet vs monotherapy as second-line therapy in advanced pancreatic cancers in terms of overall survival (OS).To estimate the efficacy of the doublet vs monotherapy as second-line therapy in advanced pancreatic cancers in terms of decrease in CA19-9 serum levels.To compare the toxicity of the doublet vs monotherapy as second-line therapy in advanced pancreatic cancers in terms of grade 3 and grade 4 toxicities as per CTCAE v5.0.To estimate and compare the quality of life for patients on doublet vs monotherapy using EORTC QLQ30 as second-line therapy in advanced pancreatic cancers. Timepoint: In general, the patients will continue to take their previous therapies according to the recommendations of the responsible physician.Patients in both arms of the study will be referred to the Dept. of Palliative care for early palliative care concurrent with chemotherapy. Estiamte at Baseline and after every 8 Weeks and 8-12 Weeks Chemotherapy in either arm will be continued till disease progression | — |
Countries
India
Contacts
Public ContactDr Prabhat Bhargava
Tata Memorial Hospital
Outcome results
None listed