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NCT01558921 · OUTCOME

Number of Patients With Disease Related Treatment Failure (DrTF)

Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial · Source last updated 2026-05-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 years follow-up after surgery

What was measured

DrTF = Either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. In case of local regrowth after wait \& watch strategy, followed by no resection or R2 resection, diagnosis local regrowth is taken. Patients lost to follow-up will be censored the last date of patient visit. Survival curves for Disease related Treatment Failure after 3 years of follow-up will be constructed using the method of Kaplan and Meier.

Analysis population: 462+450 participants started were eligible 2 + 6 participants were ineligible or withdrew informed consent

Groups in this outcome

B: 5x5Gy -> CAPOX -> Surgery

experimental group (arm B) M1 scheme M1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX

A: 5 Weeks Chemoradiation -> Surgery

control group (arm A) standard long course chemoradiotherapy standard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
B: 5x5Gy -> CAPOX -> Surgery462
A: 5 Weeks Chemoradiation -> Surgery450

Reported measurements

Source class 1

DrTF after 3 year FUP

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
B: 5x5Gy -> CAPOX -> Surgery128Not reportedNot reportedNot reportedNot reported
A: 5 Weeks Chemoradiation -> Surgery152Not reportedNot reportedNot reportedNot reported

no DrTF after 3 year FUP

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
B: 5x5Gy -> CAPOX -> Surgery334Not reportedNot reportedNot reportedNot reported
A: 5 Weeks Chemoradiation -> Surgery298Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    To detect a decrease in 3-year cumulative probability of disease-related treatment failure from 30% to 22·5%, corresponding to a hazard ratio (HR) of 0·715, a two sided log-rank test with 280 events would achieve 80% power at a two-sided α significance level of 0·05.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    To detect a decrease in 3-year cumulative probability of disease-related treatment failure from 30% to 22·5%, corresponding to a hazard ratio (HR) of 0·715, a two sided log-rank test with 280 events would achieve 80% power at a two-sided α significance level of 0·05.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        152
      title
      DrTF after 3 year FUP
    2. measurements
      1. group Id
        OG000
        value
        334
      2. group Id
        OG001
        value
        298
      title
      no DrTF after 3 year FUP
denoms
  1. counts
    1. group Id
      OG000
      value
      462
    2. group Id
      OG001
      value
      450
    units
    Participants
description
DrTF = Either local or distant relapse or death caused by the rectal carcinoma whichever comes first. In case of nonrectal cancer related death patients will be censored at date of death. In case of a second primary tumour patients will be censored at the date of diagnosis of the second primary tumour. In case of local regrowth after wait \& watch strategy, followed by no resection or R2 resection, diagnosis local regrowth is taken. Patients lost to follow-up will be censored the last date of patient visit. Survival curves for Disease related Treatment Failure after 3 years of follow-up will be constructed using the method of Kaplan and Meier.
groups
  1. description
    experimental group (arm B) M1 scheme M1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
    id
    OG000
    title
    B: 5x5Gy -> CAPOX -> Surgery
  2. description
    control group (arm A) standard long course chemoradiotherapy standard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.
    id
    OG001
    title
    A: 5 Weeks Chemoradiation -> Surgery
param Type
COUNT_OF_PARTICIPANTS
population Description
462+450 participants started were eligible 2 + 6 participants were ineligible or withdrew informed consent
reporting Status
POSTED
time Frame
3 years follow-up after surgery
title
Number of Patients With Disease Related Treatment Failure (DrTF)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice