Status:
UNKNOWN
Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration
Lead Sponsor:
Imperial College Healthcare NHS Trust
Collaborating Sponsors:
Chugai Pharma UK Limited
Conditions:
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open label study for any patients with a bile duct cancer or gallbladder cancer, who will be treated with gemcitabine and cisplatin chemotherapy (the ABC02 regime). Patients recruited onto ...
Detailed Description
The ABC02 treatment regime was established in 2010 following publication in the New England Journal of Medicine and has since become the standard of care treatment of bile duct cancers otherwise known...
Eligibility Criteria
Inclusion
- Adults with normal renal function at the start i.e. eGFR\>60, Performance status 0 and 1, controlled nausea and vomiting at baseline.
- ECOG performance status 0 or 1
- Diagnosed with either cholangio carcinoma, gallbladder cancer, pulmonary cancer or pancreatic cancer. Patients should be able to tolerate 1 litre of oral fluid pre-treatment and post treatment.
- Decision to treat with the gemcitabine and cisplatin used in the ABC02 trial.
Exclusion
- Participants under the age of 18 years old with Chronic renal impairment. The standard exclusion of renal impairment for cisplatin implies that this study would not be offered to patients, who can't be safely offered cisplatin
- Uncontrolled nausea or vomiting
- Unable to drink 1 litre of fluid
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04362449
Start Date
January 2 2019
End Date
February 2 2023
Last Update
July 15 2022
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS