Participant flow

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.

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

   FG000

   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

   FG001

   title

   A: 5 Weeks Chemoradiation -> Surgery

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   milestones

   1. achievements

      1. comment

         B: 468 enrolled, 462 eligible, 6 ineligible for participation

         group Id

         FG000

         num Subjects

         468

      2. comment

         A: 452 enrolled, 450 eligible, 2 ineligible for participation

         group Id

         FG001

         num Subjects

         452

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         462

      2. group Id

         FG001

         num Subjects

         450

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Randomisation

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         7

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         462

      2. group Id

         FG001

         num Subjects

         450

      type

      STARTED

   2. achievements

      1. comment

         460 Eligible for intention-to-treat-analyses, 2 excluded

         group Id

         FG000

         num Subjects

         460

      2. comment

         441 Eligible for intention-to-treat-analyses, 9 excluded

         group Id

         FG001

         num Subjects

         441

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Eligible Patients

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         5

      type

      patient refused surgery

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         11

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         21

      type

      Lack of Efficacy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         460

      2. group Id

         FG001

         num Subjects

         441

      type

      STARTED

   2. achievements

      1. comment

         426 had surgery with curative intention within 6 months are included in per-protocol-analyses, 34 excluded

         group Id

         FG000

         num Subjects

         426

      2. comment

         400 had surgery with curative intention within 6 months are included in per-protocol-analyses, 41 excluded

         group Id

         FG001

         num Subjects

         400

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         41

      type

      NOT COMPLETED

   title

   Started Allocated Treatment

4. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Lack of Efficacy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         426

      2. group Id

         FG001

         num Subjects

         400

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         423

      2. group Id

         FG001

         num Subjects

         398

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Surgery With Curative Intention <6m

recruitment Details

June 2011-June 2016

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