Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers
ABC06
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.
3 other identifiers
interventional
162
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2014
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJanuary 28, 2020
January 1, 2020
3.9 years
August 17, 2013
January 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Evaluated by monthly follow-up until 12 months after last patient included
Secondary Outcomes (7)
Progression-free survival
Evaluated by monthly follow-up until 12 months after last patient included
Response rate (chemotherapy arm only)
After 12 weeks of treatment
Toxicity (frequency of adverse events and serious adverse events)
Evaluated monthly until 12 months after last patient included
Quality of life
Evaluated every 3 months until 12 months after last patient included
Costs of health and social care
Evaluated every 3 months until 12 months after last patient included
- +2 more secondary outcomes
Study Arms (2)
Arm A: Active symptom control (ASC)
ACTIVE COMPARATORActive Symptom Control
Arm B: ASC with OxMdG chemotherapy
EXPERIMENTALActive Symptom Control with OxMdG chemo (Oxaliplatin, L-folinic acid \& 5FU)
Interventions
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.
L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles
5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles
Oxaliplatin 85mg/m2, q 14d, up to 12 cycles
Eligibility Criteria
You may qualify if:
- Histologically / cytologically verified, non-resectable or recurrent / metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma.
- Patients must have failed no more than one prior course of chemotherapy (gemcitabine and cisplatin) with clear evidence of disease progression.
- ECOG performance status 0-1.
- Age \>=18 years and life expectancy \>3 months.
- Adequate renal function with serum urea and serum creatinine \< 1.5 times upper limit of normal (ULN) and creatinine clearance \>= 30ml/min
- Adequate haematological function: Hb \>= 100g/l, WBC \>= 3.0 x 10\*9/L, ANC \>= 2 x 10\*9/L, platelet count \>= 100 x 10\*9/L
- Adequate liver function: total bilirubin \< 60 μmol/L and ALP, along with AST and/or ALT ≤ 5 x ULN
- Adequate biliary drainage, with no evidence of ongoing infection (patients on maintenance antibiotics are eligible when acute sepsis has resolved).
- Women of child bearing age must have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 4 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy
- Men must be willing to use an adequate method of contraception during chemotherapy and until 6 months after chemotherapy
- Patients must have given written informed consent
- Patients must be randomised and those allocated chemotherapy must start treatment within 6 weeks of diagnosis of disease progression
You may not qualify if:
- Incomplete recovery from previous therapy or unresolved biliary tree obstruction (includes ongoing neuropathy of grade \>1 from cisplatin)
- Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
- Any other serious uncontrolled medical conditions
- Clinical evidence of metastatic disease to brain
- Any pregnant or lactating woman
- Clinically significant cardiovascular disease. \[i.e. active; or \<12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension\].
- Patients must not have a history of other malignant diseases within the last 5 years (other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Christie NHS Foundation Trustlead
- Cancer Research UKcollaborator
Study Sites (17)
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, G12 0YN, 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
Related Publications (1)
Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. doi: 10.1016/S1470-2045(21)00027-9. Epub 2021 Mar 30.
PMID: 33798493DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Valle, Prof
The Christie NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist
Study Record Dates
First Submitted
August 17, 2013
First Posted
August 20, 2013
Study Start
February 1, 2014
Primary Completion
January 5, 2018
Study Completion
January 1, 2019
Last Updated
January 28, 2020
Record last verified: 2020-01