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NCT01926236 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-01-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Exclusion criteria: * 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. \[i.e. active; or \<12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension\]. \*\*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).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Active Symptom Control
    intervention Names
    1. Other: Active Symptom Control
    label
    Arm A: Active symptom control (ASC)
    type
    ACTIVE_COMPARATOR
  2. description
    Active Symptom Control with OxMdG chemo (Oxaliplatin, L-folinic acid \& 5FU)
    intervention Names
    1. Other: Active Symptom Control
    2. Drug: L-folinic acid
    3. Drug: 5 FU
    4. Drug: Oxaliplatin
    label
    Arm B: ASC with OxMdG chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A: Active symptom control (ASC)
    2. Arm B: ASC with OxMdG chemotherapy
    description
    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.
    name
    Active Symptom Control
    type
    OTHER
  2. arm Group Labels
    1. Arm B: ASC with OxMdG chemotherapy
    description
    L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles
    name
    L-folinic acid
    other Names
    1. Folinic acid
    type
    DRUG
  3. arm Group Labels
    1. Arm B: ASC with OxMdG chemotherapy
    description
    5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles
    name
    5 FU
    other Names
    1. Fluorouracil
    type
    DRUG
  4. arm Group Labels
    1. Arm B: ASC with OxMdG chemotherapy
    description
    Oxaliplatin 85mg/m2, q 14d, up to 12 cycles
    name
    Oxaliplatin
    other Names
    1. Eloxatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
162
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
    time Frame
    Evaluated by monthly follow-up until 12 months after last patient included
secondary Outcomes
  1. description
    Clinical progression assessed monthly, radiological progression assessed to RECIST criteria every 12 weeks for patients in the chemotherapy arm.
    measure
    Progression-free survival
    time Frame
    Evaluated by monthly follow-up until 12 months after last patient included
  2. measure
    Response rate (chemotherapy arm only)
    time Frame
    After 12 weeks of treatment
  3. description
    Events will be classified according to CTCAE V4.03
    measure
    Toxicity (frequency of adverse events and serious adverse events)
    time Frame
    Evaluated monthly until 12 months after last patient included
  4. description
    Assessed from patient completed questionnaire data: QLQ-C30 and QoL BiL
    measure
    Quality of life
    time Frame
    Evaluated every 3 months until 12 months after last patient included
  5. measure
    Costs of health and social care
    time Frame
    Evaluated every 3 months until 12 months after last patient included
  6. measure
    Health status (Euroqol)
    time Frame
    Evaluated every 3 months until 12 months after last patient included
  7. description
    Estimated from Euroqol and survival using published utility tariffs
    measure
    Quality adjusted life years (QALYs)
    time Frame
    Evaluated every 3 months until 12 months after last patient included
Full study description
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.
Source references
references
  1. citation
    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
    33798493
    type
    DERIVED
Source notices and limitations
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        <div class="pdq-content-list"><ol id="_555"><li>A multicenter phase III trial in the United Kingdom (<a href="/clinicaltrials/NCT01926236">ABC-06</a> [NCT01926236]) included 162 patients with locally advanced or metastatic biliary tract cancer and documented radiological disease progression on first-line cisplatin and ge
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      1. context
        Updated: March 28, 2025
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        display
        March 28, 2025

    Preserved source evidence · Not medical advice