ABC-02 regime - gemcitabine and cisplatin with a shortened hydration time and administration of a newer antiemetic

ABC-02 regime - gemcitabine and cisplatin with currently approved hydration time and administration of the current choice of antiemetic

Gallbladder Cancer

Hydration is reduced to 1 hour and 40 minutes and Akynzeo is administered as an oral drug instead of Ondansetron being given as an IV before chemotherapy.

Shortened hydration time and dispensary of Akynzeo

Hydration remains at around 6 hours and 30 minutes due to no oral fluids being consumed prior to treatment and normal saline being administered for 90 minutes before cisplatin and then for 2 hours after cisplatin and before gemcitabine administration

Standard of care

Imperial College Healthcare NHS Trust

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

A Prospective Study of Tolerance Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

To compare the proportion of patients who experience CTCAE V3.0 grade 3 or 4 nausea (using a shortened hydration protocol and a modern antiemetic regimen) with those who are in the ABC02 trial arm which used a longer hydration procedure and a standard antiemetic regimen

To compare proportion of patients who experience CTCAE V3.0 grade 3 or 4 impaired renal function

To compare proportion of patients who have a complete response i.e. no nausea and vomiting recorded as a toxicity

To compare the proportion of patients who experience renal dysfunction (a deterioration of calculated GFR of below 60)

To determine the incidence of early and delayed chemotherapy induced emesis using the MAT antiemesis tool

To determine the incidence of nocturia in the first night after chemotherapy

Measuring the length of hospital visit (time in to time out) for each patient per treatment visit and comparing the difference between arms

Chugai Pharma UK Limited

patients with biliary obstruction will undergo endoscopic stenting.

Biliary stenting

Updated cancer treatment guidelines for patients and physicians

All India Institute of Medical Sciences

Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.

Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial

gallbladder neoplasms/vomiting

Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.

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