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    Clinical Trial Results:
    A randomised control trial to study the side effect profile and to establish measures of efficacy using Photofrin or 5 aminolaevulinic acid (ALA) photodynamic therapy in the eradication of dysplasia in Barrett’s columnar lined oesophagus

    Summary
    EudraCT number
    2005-005528-15
    Trial protocol
    GB  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Oct 2019
    First version publication date
    18 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    05/059
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street, London, United Kingdom,
    Public contact
    Gower Street, London , United Kingdom, WC1E 6BT, Joint Research Office, ctimps@ucl.ac.uk
    Scientific contact
    Gower Street, London , United Kingdom, WC1E 6BT, Joint Research Office, ctimps@ucl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether PDT using ALA is more efficacious for the complete ablation of high grade dysplasia in Barrett’s oesophagus than Photofrin. To establish which drug has a better side effect profile.
    Protection of trial subjects
    A routine chest X ray will be taken before and 24-48 hours after PDT. Pleural effusion have been noted post-PDT with the licensed and study medications. Dysphagia is a recognised complication of photodynamic therapy sometimes resulting in admission to hospital for rehydration and possible oesophageal dilation. Nausea and vomiting are relatively common post photodynamic therapy. This normal settles promptly and and does not prolong the patient’s length of stay. Aspiration pneumonia has been noted after photodynamic therapy. The occurrence of pneumonias is expected in a small number patients and rarely results in prolonged length of stay. Pigmented urine has been noted on the day following ALA administration. This is thought to be related to the metabolism of the medication via the haem-biosynthesis pathway and has not resulted in any long term problems. If this occurs these patients will be work-up in the usual way in consultation with the urologists. Liver function tests will be taken 1-2 days after treatment. If more than twice the upper limit of normal, they will continue to be taken every 1-2 days until bilirubin and ALT return to within twice the upper limit of normal or until discharge, whichever is earlier. Transient abnormalities in liver function tests have been reported with ALA photodynamic therapy. All have resolved spontaneously without long-term sequelae. Hypotension has been noted with the oral administration of ALA. All patients are now rehydated prior to drug administration and excluded from the study if taking depot psychotropic medications.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Feb 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    57
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of 128 patients that were screened for eligibility from 2006–2009, 79 patients were recruited to the study and from these, 64 underwent randomisation

    Period 1
    Period 1 title
    Trial Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Study Arm
    Arm description
    PDT with oral ALA administration (study arm)
    Arm type
    Experimental

    Investigational medicinal product name
    Aminolaevulinic Acid (ALA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral ALA PDT: • Normal saline infusion 12 hours prior to administration of ALA only. • Anti-emetic: Granisetron (30 minutes prior to ALA administration). • Following ingestion of ALA, patients must minimise exposure to sunlight and avoid strong indoor lighting for 36 hours. • Patients receive ALA (60 mg/kg body weight) in 50 ml of distilled water in 3 divided doses at 5 hours, 4 hours and 3 hours before therapy. Patients receive light treatment ideally at 5 hours (but in any case not more than 7 hours) after initial oral ALA ingestion via a diffuser fibre at 1132J/cm (or 200J/cm2 in an 18mm diameter balloon or bolster).

    Arm title
    Standard Treatment Control
    Arm description
    PDT with IV Photofrin administration (standard treatment control)
    Arm type
    Active comparator

    Investigational medicinal product name
    Photofrin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV Photofrin PDT (Standard treatment parameters): • Drug is administered intravenously (2mg/kg) by a cannula placed in a large bore vein in the antecubital fossa 3 days before light treatment.

    Number of subjects in period 1
    Study Arm Standard Treatment Control
    Started
    34
    30
    Completed
    34
    30

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Study Arm
    Reporting group description
    PDT with oral ALA administration (study arm)

    Reporting group title
    Standard Treatment Control
    Reporting group description
    PDT with IV Photofrin administration (standard treatment control)

    Primary: Complete reversal of high-grade dysplasia (CR-HGD) at 1 year post-PDT

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    End point title
    Complete reversal of high-grade dysplasia (CR-HGD) at 1 year post-PDT [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 year follow-up
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Of the 64 patients randomised, 34 were photosensitised with ALA and 30 with Photofrin. CR-HGD was 16/34 (47 %) in the ALA group and 12/30 (40 %) in the Photofrin group (Fisher’s exact test00.62). A Kaplan– Meier analysis of probability of the remaining without dysplasia demonstrated no significant difference in dysplasia-free interval between the two groups (χ20 0.91, p00.34)
    End point values
    Study Arm Standard Treatment Control
    Number of subjects analysed
    34
    30
    Units: percent
        number (not applicable)
    47
    40
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From randomisation to end of follow-up period
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    ctcae
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Randomised patients
    Reporting group description
    -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events are not available to be added to this dataset.
    Serious adverse events
    Randomised patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 64 (20.31%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    Cardiac disorders
    Pleural effusion
         subjects affected / exposed
    3 / 64 (4.69%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Chest pain
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Suicide
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Skin and subcutaneous tissue disorders
    Sunburn
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Randomised patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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