A randomized, open-label, double arm, phase III study of doublet vs monotherapy in advanced pancreatic cancer who have failed first-line therapy. - Panc-SELECT

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•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.

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