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Brief Title: Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers
Official Title: A Phase III, Randomised, Multicentre Open-label Study of Active Symptom Control (ASC) Alone or ASC With Oxaliplatin/ 5F-U Chemotherapy for Patients With Locally Advanced/ Metastatic Biliary Tract Cancers Previously Treated With Cisplatin/ Gemcitabine Chemotherapy.
Study ID: NCT01926236
Brief Summary: The purpose of this study is to determine whether fit patients (with ECOG performance score of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the second-line setting (after prior therapy with cisplatin and gemcitabine) in terms of overall survival.
Detailed Description: Active chemotherapy drugs for the treatment of ABC include gemcitabine, fluoropyrimidines and platinum agents. The randomized NCRN phase III ABC-02 trial provided level A evidence supporting first-line combination cisplatin and gemcitabine (CisGem) chemotherapy in ABC. To date, there is no randomized data to support the use of second-line chemotherapy in ABC. In this setting only a small number of retrospective and prospective (phase II) studies employing multiple different chemotherapy schedules have been conducted (level C). Thus, active symptom control (ASC) is the current standard of care after development of resistance to first-line chemotherapy. Oxaliplatin has activity in several gastrointestinal tumours and has synergistic activity with a favourable toxicity profile when used in combination with 5-FU. Several studies using mFOLFOX for biliary tract tumours have provided promising efficacy data and acceptable toxicity. The aim of this trial is to determine if patients with ABC benefit with respect to survival from the addition of mFOLFOX chemotherapy to ASC in the second-line setting after progression to first-line treatment with CisGem. This study will establish the standard of care for patients with ABC who have progressed on first line CisGem chemotherapy. This is a randomised phase III, multi-centre, controlled, open-label trial of patients with advanced biliary tract cancer with evidence of disease progression after prior CisGem chemotherapy treatment. Eligible patients (ECOG 0-1, adequate haematological, renal and liver function, adequate biliary drainage, with no evidence of ongoing infection) will be randomized to receive either ASC ("standard" arm) or ASC with oxaliplatin/5-FU chemotherapy ("experimental" arm). The total number of participants planned is 162 (randomized 1:1). At randomisation the following factors will be controlled for: serum albumin level, platinum sensitivity (determined from first-line therapy) and locally advanced vs metastatic disease. The primary end point is overall survival. Quality of life and economic evaluation will assess the impact on patients and relative cost effectiveness of the intervention. Archival paraffin-embedded tissue will be collected at baseline and prospective blood samples (whole blood, serum and plasma) will be collected for translational research.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Bristol Haematology & Oncology Centre, Bristol, , United Kingdom
North Cumbria University Hospitals, Carlisle, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Castle Hill Hospital, Hull, , United Kingdom
St James' Hospital, Leeds, , United Kingdom
Clatterbridge Cancer Centre, Liverpool, , United Kingdom
Guy's and St Thomas' Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
University College London, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Name: Juan Valle, Prof
Affiliation: The Christie NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR