NCT01926236 - Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers | Biotech Hunter

Enrollment

162

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

January 5, 2018

Study Completion Date

January 31, 2019

Conditions

Biliary Tract CancerGallbladder CancerCholangiocarcinomaAmpullary Cancer

Interventions

OTHER

Active Symptom Control

Active Symptom Control: monthly clinical review and active symptom control as needed, including biliary drainage, antibiotics, analgesia, steroids, anti-emetics, other palliative treatment for symptom control, palliative radiotherapy, blood transfusion.

DRUG

L-folinic acid

L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles

DRUG

5 FU

5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles

DRUG

Oxaliplatin

Oxaliplatin 85mg/m2, q 14d, up to 12 cycles

Trial Locations (17)

Unknown

Queen Elizabeth Hospital, Birmingham

Bristol Haematology & Oncology Centre, Bristol

North Cumbria University Hospitals, Carlisle

Castle Hill Hospital, Hull

St James' Hospital, Leeds

Clatterbridge Cancer Centre, Liverpool

Guy's and St Thomas' Hospital, London

Hammersmith Hospital, London

Royal Free Hospital, London

University College London, London

Maidstone Hospital, Maidstone

The Christie NHS Foundation Trust, Manchester

Nottingham City Hospital, Nottingham

Churchill Hospital, Oxford

Weston Park Hospital, Sheffield

Southampton General Hospital, Southampton

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow