Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers
NCT ID: NCT01926236
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2014-02-28
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Active symptom control (ASC)
Active Symptom Control
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.
Arm B: ASC with OxMdG chemotherapy
Active Symptom Control with OxMdG chemo (Oxaliplatin, L-folinic acid \& 5FU)
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.
L-folinic acid
L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles
5 FU
5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles
Oxaliplatin
Oxaliplatin 85mg/m2, q 14d, up to 12 cycles
Interventions
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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.
L-folinic acid
L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles
5 FU
5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles
Oxaliplatin
Oxaliplatin 85mg/m2, q 14d, up to 12 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
The Christie NHS Foundation Trust
OTHER
Responsible Party
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Juan Valle
Medical Oncologist
Principal Investigators
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Juan Valle, Prof
Role: PRINCIPAL_INVESTIGATOR
The Christie NHS Foundation Trust
Locations
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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
Countries
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References
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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.
Other Identifiers
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A16281
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2013-001812-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTSp048
Identifier Type: -
Identifier Source: org_study_id
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