It is a two arm phase III study of double vs single therapy in pancreatic cancer for those who have failed chemotherapy(first line treatment)
- Conditions
- Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
- Registration Number
- CTRI/2022/02/040235
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 â?? 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br/ ><br>Estiamte at Baseline and after every 8 Weeks and 8-12 Weeks Chemotherapy in either arm will be continued till disease progression <br/ ><br>
- Secondary Outcome Measures
Name Time Method