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Biliary Tract CancerPhase 3ABC06NCT01926236

Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers

A Phase 3 study testing L-folinic acid, 5 FU and Oxaliplatin in people with Biliary Tract Cancer and Gallbladder Cancer, run by The Christie NHS Foundation Trust at 17 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
L-folinic acid, 5 FU and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
17 sitesUnited Kingdom
Study dates
Feb 2014to Jan 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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].
  • Hypertension grading of ≥ 3 is an exclusion criteria (CTCAE v4.03). However, patients who have controlled hypertension with medication and/or diet may be included at the investigator's discretion. (This should be noted in the medical history section of the CRF).
  • 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).

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United Kingdom17 sites

  • Queen Elizabeth Hospital

    Birmingham

  • Bristol Haematology & Oncology Centre

    Bristol

  • North Cumbria University Hospitals

    Carlisle

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • 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

Other trials in United Kingdom

About this study

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.

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.

Read the 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.

Being tested
Active Symptom Control, L-folinic acid, 5 FU, Oxaliplatin
Medical subject headings
Biliary Tract Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Symptom ControlOther

    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 acidDrug

    Also called Folinic acid

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

  • 5 FUDrug

    Also called Fluorouracil

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

  • OxaliplatinDrug

    Also called Eloxatin

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

Study groups in NCT01926236
Study groupRoleWhat they receive
Arm A: Active symptom control (ASC)Active comparatorActive Symptom Control
Receives: Other: Active Symptom Control
Arm B: ASC with OxMdG chemotherapyExperimentalActive Symptom Control with OxMdG chemo (Oxaliplatin, L-folinic acid \& 5FU)
Receives: Other: Active Symptom Control; Drug: L-folinic acid; Drug: 5 FU; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Evaluated by monthly follow-up until 12 months after last patient included

Secondary outcomes (7)

  1. Progression-free survival

    Clinical progression assessed monthly, radiological progression assessed to RECIST criteria every 12 weeks for patients in the chemotherapy arm.

    Measured: Evaluated by monthly follow-up until 12 months after last patient included

  2. Response rate (chemotherapy arm only)

    Measured: After 12 weeks of treatment

  3. Toxicity (frequency of adverse events and serious adverse events)

    Events will be classified according to CTCAE V4.03

    Measured: Evaluated monthly until 12 months after last patient included

  4. Quality of life

    Assessed from patient completed questionnaire data: QLQ-C30 and QoL BiL

    Measured: Evaluated every 3 months until 12 months after last patient included

  5. Costs of health and social care

    Measured: Evaluated every 3 months until 12 months after last patient included

  6. Health status (Euroqol)

    Measured: Evaluated every 3 months until 12 months after last patient included

  7. Quality adjusted life years (QALYs)

    Estimated from Euroqol and survival using published utility tariffs

    Measured: Evaluated every 3 months until 12 months after last patient included

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completion5 Jan 2018
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01926236
Sponsor's protocol ID
CFTSp048
Other IDs
A16281, 2013-001812-30
Acronym
ABC06
Status last verified
Jan 2020
First submitted
17 Aug 2013
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33798493

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing L-folinic acid, 5 FU and Oxaliplatin in people with Biliary Tract Cancer and Gallbladder Cancer, run by The Christie NHS Foundation Trust at 17 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Evaluated by monthly follow-up until 12 months after last patient included). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01926236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

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