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    Clinical Trial Results:
    Treatment of patients with locally advanced rectal cancer. TEGAFOX (UFT/leukovorin og Oxaliplatin) before, during and after curatively intended radiotherapy. A Danish phase I/II trial

    Summary
    EudraCT number
    		 2004-001347-29
    Trial protocol
    		 DK  
    Global end of trial date
    07 May 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2021
    First version publication date
    07 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    04.08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J.B. Winsløws Vej 2, entrance 140, basement, Odense C, Denmark, 5000
    Public contact
    Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
    Scientific contact
    Per Pfeiffer, Odense University Hospital, +45 26283844, per.pfeiffer@rsyd.dk
    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
    07 May 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess toxicity and feasibility of TEGAFOX followed by radiochemotherapy (UFT + oxaliplatin) in patients with LARC
    Protection of trial subjects
    Average radiation doses for organs at risk (small intestine and bladder) were calculated and recorded. Heating pads were available during administration of i.v. chemotherapy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    10
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From May 2005 to March 2009, 18 patients (nine men and nine women) were treated according to this phase I trial.

    Pre-assignment
    Screening details
    		 All patients had biopsy-proven non-resectable (primary or recurrent) rectal adenocarcinoma (LARC). Patients were eligible if the tumour was fixed to the pelvic wall or otherwise non-resectable as judged clinically by an experienced colorectal surgeon.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Level 0
    Arm description
    		 Tegafox 1: 130 RCT: 30x6 Tegafox 2: 130
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30mg/m2/week i.v.

    Arm title
    		 Level 1
    Arm description
    		 Tegafox 1: 130 RCT: 40x6 Tegafox 2: 130
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40mg/m2/week i.v.

    Arm title
    		 Level 2
    Arm description
    		 Tegafox 1: 130 RCT: 50x6 Tegafox 2: 130
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg/m2/week i.v.

    Arm title
    		 Level 3
    Arm description
    		 Tegafox 1: 130 RCT: 60x5 Tegafox 2: 130
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60mg/m2/week i.v.

    Number of subjects in period 1
    		Level 0 Level 1 Level 2 Level 3
    Started
    6
    6
    3
    3
    Completed
    6
    6
    3
    1
    Not completed
    0
    0
    0
    2
         Adverse event, non-fatal
    -
    -
    -
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Level 0
    Reporting group description
    		 Tegafox 1: 130 RCT: 30x6 Tegafox 2: 130

    Reporting group title
    Level 1
    Reporting group description
    		 Tegafox 1: 130 RCT: 40x6 Tegafox 2: 130

    Reporting group title
    Level 2
    Reporting group description
    		 Tegafox 1: 130 RCT: 50x6 Tegafox 2: 130

    Reporting group title
    Level 3
    Reporting group description
    		 Tegafox 1: 130 RCT: 60x5 Tegafox 2: 130

    Primary: Maximal tolerable dose

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    End point title
    		 Maximal tolerable dose [1]
    End point description
    Toxicity was graded according to NCI Common Toxicity Criteria version 2.0. DLT was reached if grade 3 toxicity was observed. Cohorts of three to six patients were entered at each dose level and each cohort was evaluated for the entire combined treatment course before dose escalation was allowed. If one patient at a given dose level developed DLT, three additional patients were planned to be treated at that dose level. If zero or one out of three/six patients developed DLT the dose was escalated with 10 mg/m 2/week. If two or more patients out of three or six developed DLT the MTD was reached.
    End point type
    Primary
    End point timeframe
    6 weeks
    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: Maximal tolerable dose cannot be statistically analyzed. Toxicity was graded according to NCI Common Toxicity Criteria version 2.0. DLT was reached if grade 3 toxicity was observed. Cohorts of three to six patients were entered at each dose level and each cohort was evaluated for the entire combined treatment course before dose escalation was allowed. See also publication.
    End point values
    		 Level 0 Level 1 Level 2 Level 3
    Number of subjects analysed
    6
    6
    3
    3
    Units: patients without DLT
    5
    5
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    One year
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Level 0
    Reporting group description
    		 -

    Reporting group title
    Level 1
    Reporting group description
    		 -

    Reporting group title
    Level 2
    Reporting group description
    		 -

    Reporting group title
    Level 3
    Reporting group description
    		 -

    Serious adverse events
    		 Level 0 Level 1 Level 2 Level 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Level 0 Level 1 Level 2 Level 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 6 (66.67%)
    6 / 6 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
         occurrences all number
    4
    6
    3
    3
    Pain
         subjects affected / exposed
    4 / 6 (66.67%)
    3 / 6 (50.00%)
    3 / 3 (100.00%)
    2 / 3 (66.67%)
         occurrences all number
    4
    3
    3
    2
    Gastrointestinal disorders
    Nausea/vomiting
         subjects affected / exposed
    5 / 6 (83.33%)
    4 / 6 (66.67%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
         occurrences all number
    5
    4
    3
    3
    Diarrhea
         subjects affected / exposed
    4 / 6 (66.67%)
    4 / 6 (66.67%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
         occurrences all number
    4
    4
    3
    3
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    2
    1
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22248062
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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