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    Clinical Trial Results:
    Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery

    Summary
    EudraCT number
    		 2010-023957-12
    Trial protocol
    		 SE   NL   ES   SI   DK  
    Global end of trial date
    08 Sep 2026

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2026
    First version publication date
    30 Oct 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RAPIDO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01558921
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 OMON: NL-OMON47895
    Sponsors
    Sponsor organisation name
    Universitair Medisch Centrum Groningen
    Sponsor organisation address
    Hanzeplein 1, Groningen, Netherlands, 9713 GZ
    Public contact
    Professor Geke Hospers, Universitair Medisch Centrum Groningen, g.a.p.hospers@umcg.nl
    Scientific contact
    Professor Geke Hospers, Universitair Medisch Centrum Groningen, g.a.p.hospers@umcg.nl
    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
    08 Sep 2026
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Sep 2026
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2026
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To decrease disease related treatment failure (DrTF)
    Protection of trial subjects
    TO BE ANSWERED
    Background therapy
    		 TO BE ANSWERED
    Evidence for comparator
    		 standard therapy
    Actual start date of recruitment
    21 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 361
    Country: Number of subjects enrolled
    Norway: 23
    Country: Number of subjects enrolled
    Slovenia: 36
    Country: Number of subjects enrolled
    Spain: 119
    Country: Number of subjects enrolled
    Sweden: 332
    Country: Number of subjects enrolled
    Denmark: 29
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    920
    EEA total number of subjects
    900
    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)
    556
    From 65 to 84 years
    364
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was between 18-06-2011 (first informed consent) and 02-06-2016 (last randomization).

    Pre-assignment
    Screening details
    		 • Medical history, concomitant medication and medical complaints • Physical examination • Rectoscopy and / or colonoscopy. A biopsy of the tumour might be taken • If significant for the study an X-ray of the colon will be taken • CT of lungs, abdomen and pelvis and a MRI of the pelvis will be performed to examine size and spread of the tumour.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of care
    Arm description
    		 Long-course radiotherapy (1.8-2 Gy x 25-28) with concomitant capecitabine. After a “waiting period” of 8 weeks (±2 weeks) during which response is evaluated, surgery according to TME/PME principles will be performed. In this arm it is allowed according to the local protocol of the participating institute to admit after recovery, optimally within 6-8 weeks, post-operative adjuvant chemotherapy consisting of 8 cycles oxaliplatin/capecitabine (or alternatively 24 weeks of FOLFOX4).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    capecitabine
    Investigational medicinal product code
    L01BC06
    Other name
    Xeloda
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    825 mg/m2 (twice daily) day 1-33-38 pre-surgery and optional 1000 mg/m2 (twice daily) day 1-14 every 3 weeks post-surgery

    Investigational medicinal product name
    oxaliplatin
    Investigational medicinal product code
    L01XA03
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    130 mg/m2 day 1 every 3 weeks

    Arm title
    		 Experimental
    Arm description
    		 Short-course radiotherapy (5 Gy x 5). Within 11-18 days after the last day of radiotherapy pre-operative systemic chemotherapy with oxaliplatin/capecitabine will commence and is delivered in 6 cycles. Alternatively 18 weeks cycles of FOLFOX4 is an option. Response is evaluated after the systemic chemotherapy. Within 2-4 weeks after the final chemotherapy cycle surgery according to TME/PME principles will be performed. No postoperative therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    capecitabine
    Investigational medicinal product code
    L01BC06
    Other name
    Xeloda
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg/m2 (twice daily) day 1-14 every 3 weeks

    Investigational medicinal product name
    oxaliplatin
    Investigational medicinal product code
    L01XA03
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    130 mg/m2 day 1 every 3 weeks

    Investigational medicinal product name
    leucovorin
    Investigational medicinal product code
    V03AF03
    Other name
    folonic acid, calcium folinate
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    leucovorin (200 mg/m2) administered as a 2-hour infusion on day 1 and day 2

    Investigational medicinal product name
    fluorouracil
    Investigational medicinal product code
    L01BC02
    Other name
    5-FU
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    a loading dose of 5-FU (400 mg/m2) IV bolus, then 5-FU (600 mg/m2) administered for a period of 22 hours on day 1 and day 2 every 2 weeks

    Number of subjects in period 1
    		Standard of care Experimental
    Started
    452
    468
    Completed
    400
    426
    Not completed
    52
    42
         Adverse event, serious fatal
    3
    1
         Consent withdrawn by subject
    2
    3
         personal event
    2
    1
         refused surgery or watch &wait
    16
    -
         progressive disease
    25
    10
         refused surgery or not fit or watch &wait
    -
    22
         switched arm
    3
    1
         ineligible
    1
    3
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 920 920
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age at randomization
    Units: years
        median (full range (min-max))
    		 62 (23 to 84) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 303 303
        Male
    		 617 617

    End points

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    End points reporting groups
    Reporting group title
    Standard of care
    Reporting group description
    		 Long-course radiotherapy (1.8-2 Gy x 25-28) with concomitant capecitabine. After a “waiting period” of 8 weeks (±2 weeks) during which response is evaluated, surgery according to TME/PME principles will be performed. In this arm it is allowed according to the local protocol of the participating institute to admit after recovery, optimally within 6-8 weeks, post-operative adjuvant chemotherapy consisting of 8 cycles oxaliplatin/capecitabine (or alternatively 24 weeks of FOLFOX4).

    Reporting group title
    Experimental
    Reporting group description
    		 Short-course radiotherapy (5 Gy x 5). Within 11-18 days after the last day of radiotherapy pre-operative systemic chemotherapy with oxaliplatin/capecitabine will commence and is delivered in 6 cycles. Alternatively 18 weeks cycles of FOLFOX4 is an option. Response is evaluated after the systemic chemotherapy. Within 2-4 weeks after the final chemotherapy cycle surgery according to TME/PME principles will be performed. No postoperative therapy.

    Primary: DrTF at 3 years

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    End point title
    		 DrTF at 3 years
    End point description
    Disease related Treatment Failure
    End point type
    Primary
    End point timeframe
    3 years
    End point values
    		 Standard of care Experimental
    Number of subjects analysed
    450
    462
    Units: percentage
        number (confidence interval 5%)
    30.4 (26.1 to 34.6)
    23.7 (19.8 to 27.6)
    Attachments
    		 DrTF
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    calculated HRs and 95% CIs using Cox regression.
    Comparison groups
    Standard of care v Experimental
    Number of subjects included in analysis
    912
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During therapy
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 During treatment

    Reporting group title
    Standard Care
    Reporting group description
    		 -

    Reporting group title
    Standard Care - adjuvant chemotherapy
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental Standard Care Standard Care - adjuvant chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    177 / 460 (38.48%)
    87 / 441 (19.73%)
    64 / 187 (34.22%)
         number of deaths (all causes)
    4
    4
    0
         number of deaths resulting from adverse events
    4
    4
    0
    Investigations
    Dehydration/laboratory deviation
         subjects affected / exposed
    3 / 460 (0.65%)
    5 / 441 (1.13%)
    4 / 187 (2.14%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thromboembolic
         subjects affected / exposed
    13 / 460 (2.83%)
    6 / 441 (1.36%)
    2 / 187 (1.07%)
         occurrences causally related to treatment / all
    13 / 13
    6 / 6
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiovascular disease
         subjects affected / exposed
    8 / 460 (1.74%)
    10 / 441 (2.27%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    8 / 8
    10 / 10
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Weakness/Fatigue
         subjects affected / exposed
    1 / 460 (0.22%)
    3 / 441 (0.68%)
    2 / 187 (1.07%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Other
         subjects affected / exposed
    9 / 460 (1.96%)
    3 / 441 (0.68%)
    4 / 187 (2.14%)
         occurrences causally related to treatment / all
    9 / 9
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain/obstipation/obstruction
         subjects affected / exposed
    27 / 460 (5.87%)
    10 / 441 (2.27%)
    3 / 187 (1.60%)
         occurrences causally related to treatment / all
    27 / 27
    10 / 10
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood loss (oral, rectal, urine)
         subjects affected / exposed
    6 / 460 (1.30%)
    2 / 441 (0.45%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    6 / 6
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    45 / 460 (9.78%)
    11 / 441 (2.49%)
    5 / 187 (2.67%)
         occurrences causally related to treatment / all
    45 / 45
    11 / 11
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea/vomiting/anorexia
         subjects affected / exposed
    8 / 460 (1.74%)
    1 / 441 (0.23%)
    2 / 187 (1.07%)
         occurrences causally related to treatment / all
    8 / 8
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Other, abdominal
         subjects affected / exposed
    16 / 460 (3.48%)
    4 / 441 (0.91%)
    6 / 187 (3.21%)
         occurrences causally related to treatment / all
    16 / 16
    4 / 4
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary
         subjects affected / exposed
    6 / 460 (1.30%)
    2 / 441 (0.45%)
    2 / 187 (1.07%)
         occurrences causally related to treatment / all
    6 / 6
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    Psychiatric disorders
    Psychological
         subjects affected / exposed
    1 / 460 (0.22%)
    2 / 441 (0.45%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Infections and infestations
    Infectious, abdominal
         subjects affected / exposed
    11 / 460 (2.39%)
    6 / 441 (1.36%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    11 / 11
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Infectious, other
         subjects affected / exposed
    18 / 460 (3.91%)
    8 / 441 (1.81%)
    8 / 187 (4.28%)
         occurrences causally related to treatment / all
    18 / 18
    8 / 8
    8 / 8
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental Standard Care Standard Care - adjuvant chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    382 / 460 (83.04%)
    427 / 441 (96.83%)
    135 / 187 (72.19%)
    Nervous system disorders
    Neurological toxicity
         subjects affected / exposed
    382 / 460 (83.04%)
    31 / 441 (7.03%)
    135 / 187 (72.19%)
         occurrences all number
    1439
    53
    637
    General disorders and administration site conditions
    Faecal incontinence
         subjects affected / exposed
    32 / 460 (6.96%)
    43 / 441 (9.75%)
    2 / 187 (1.07%)
         occurrences all number
    55
    88
    2
    Fatigue/lethargy
         subjects affected / exposed
    310 / 460 (67.39%)
    258 / 441 (58.50%)
    126 / 187 (67.38%)
         occurrences all number
    934
    702
    464
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    5 / 460 (1.09%)
    1 / 441 (0.23%)
    1 / 187 (0.53%)
         occurrences all number
    6
    1
    1
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    25 / 460 (5.43%)
    3 / 441 (0.68%)
    7 / 187 (3.74%)
         occurrences all number
    41
    3
    9
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    213 / 460 (46.30%)
    159 / 441 (36.05%)
    39 / 187 (20.86%)
         occurrences all number
    476
    360
    80
    Diarrhoea
         subjects affected / exposed
    261 / 460 (56.74%)
    250 / 441 (56.69%)
    103 / 187 (55.08%)
         occurrences all number
    670
    672
    262
    Nausea
         subjects affected / exposed
    248 / 460 (53.91%)
    142 / 441 (32.20%)
    94 / 187 (50.27%)
         occurrences all number
    589
    312
    246
    Oral mucositis
         subjects affected / exposed
    52 / 460 (11.30%)
    23 / 441 (5.22%)
    21 / 187 (11.23%)
         occurrences all number
    74
    35
    33
    Proctitis
         subjects affected / exposed
    48 / 460 (10.43%)
    54 / 441 (12.24%)
    3 / 187 (1.60%)
         occurrences all number
    65
    99
    4
    Rectal bleeding
         subjects affected / exposed
    98 / 460 (21.30%)
    94 / 441 (21.32%)
    2 / 187 (1.07%)
         occurrences all number
    150
    172
    6
    Rectal mucositis
         subjects affected / exposed
    46 / 460 (10.00%)
    56 / 441 (12.70%)
    5 / 187 (2.67%)
         occurrences all number
    74
    125
    5
    Rectal pain
         subjects affected / exposed
    110 / 460 (23.91%)
    140 / 441 (31.75%)
    22 / 187 (11.76%)
         occurrences all number
    178
    347
    45
    Vomiting
         subjects affected / exposed
    100 / 460 (21.74%)
    40 / 441 (9.07%)
    39 / 187 (20.86%)
         occurrences all number
    162
    55
    53
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    9 / 460 (1.96%)
    6 / 441 (1.36%)
    3 / 187 (1.60%)
         occurrences all number
    30
    8
    3
    Hand-foot syndrome
         subjects affected / exposed
    142 / 460 (30.87%)
    82 / 441 (18.59%)
    72 / 187 (38.50%)
         occurrences all number
    299
    146
    200
    Radiation dermatitis
         subjects affected / exposed
    26 / 460 (5.65%)
    126 / 441 (28.57%)
    1 / 187 (0.53%)
         occurrences all number
    33
    277
    1
    Rash maculopapular
         subjects affected / exposed
    18 / 460 (3.91%)
    18 / 441 (4.08%)
    5 / 187 (2.67%)
         occurrences all number
    23
    27
    5
    Renal and urinary disorders
    Cystitis
         subjects affected / exposed
    39 / 460 (8.48%)
    97 / 441 (22.00%)
    9 / 187 (4.81%)
         occurrences all number
    56
    232
    13
    Metabolism and nutrition disorders
    Weight loss
         subjects affected / exposed
    81 / 460 (17.61%)
    49 / 441 (11.11%)
    22 / 187 (11.76%)
         occurrences all number
    142
    69
    31

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Mar 2016
    In protocol version 3.0, 3-year disease free survival (DFS) was the primary endpoint. But DFS is not a suitable outcome measure in a neo-adjuvant setting where all patients experience disease at time of randomisation. Some of the patients will never become free of disease. For this reason the protocol was amended. A new primary endpoint was formulated in protocol version 3.1: Time to Disease related Treatment Failure (tDrTF).
    04 Sep 2019
    After a median follow-up of more than 3 years, the number of events is much lower than anticipated and the required number (n=452) would never be reached. Reasons for the lower number of events are: change of the endpoint in amendment 3.1 (e.g. death due to other reasons is no event, new primary other tumor is no event), maximum duration of follow-up of 5 year (statistical programs assume endless follow-up) and perhaps better overall outcome of patients. Therefore, the hypothesis is changed from 50% → 40% Disease related Treatment Failures into 30 → 22.5% DrTF events. These numbers correspond to 280 required events. Additional data-collection for recurrence and survival at 7.5 and 10 years

    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/42556586
    http://www.ncbi.nlm.nih.gov/pubmed/41020329
    http://www.ncbi.nlm.nih.gov/pubmed/40354950
    http://www.ncbi.nlm.nih.gov/pubmed/40183423
    http://www.ncbi.nlm.nih.gov/pubmed/40276906
    http://www.ncbi.nlm.nih.gov/pubmed/39522647
    http://www.ncbi.nlm.nih.gov/pubmed/38636289
    http://www.ncbi.nlm.nih.gov/pubmed/37889954
    http://www.ncbi.nlm.nih.gov/pubmed/38192084
    http://www.ncbi.nlm.nih.gov/pubmed/38001376
    http://www.ncbi.nlm.nih.gov/pubmed/37713932
    http://www.ncbi.nlm.nih.gov/pubmed/37609761
    http://www.ncbi.nlm.nih.gov/pubmed/36996624
    http://www.ncbi.nlm.nih.gov/pubmed/36871393
    http://www.ncbi.nlm.nih.gov/pubmed/36661037
    http://www.ncbi.nlm.nih.gov/pubmed/36581138
    http://www.ncbi.nlm.nih.gov/pubmed/35447283
    http://www.ncbi.nlm.nih.gov/pubmed/33662297
    http://www.ncbi.nlm.nih.gov/pubmed/33301740
    http://www.ncbi.nlm.nih.gov/pubmed/32240909
    http://www.ncbi.nlm.nih.gov/pubmed/23742033
    http://www.ncbi.nlm.nih.gov/pubmed/42455037
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    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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