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← Eloxatin: metastatic Rectal Carcinoma (first-line)

NCT01558921 · STUDY IN CONTEXT

Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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

→

secondary · POSTED

Number of patients in the experimental arm receiving 5 fractions of x 5 Gy (5x5Gy) radiotherapy followed by at least 75% of the prescribed chemotherapy. In the standard arm receiving the prescribed chemoradiotherapy.

901 of the 920 patients were evaluable

→

secondary · POSTED

Number of patients with a Circumferential Resection Margin (CRM) \> 1 mm

Patients with a resection within 6 months after the end of preoperative treatment

→

secondary · POSTED

Number of patients with a Pathological Complete Response (pCR) after neo-adjuvant treatment

Participants with a resection within 6 months after the end of preoperative treatment

→

secondary · POSTED

Number of patients with surgical complications: wound rupture, bleeding, infection, rectal anastomotic leak

Patients undergoing standard surgery with curative intention

→

secondary · POSTED

Quality of life QLQ-C30 core questionnaire EORTC quality-of-life instrument for use in international clinical trials in oncology A total Quality of Life Questionnaire (QLQ) score can range from 0 to 88, higher score means worse outcome.

574 Patients without DrTF at 3 years post surgery were eligible to receive the questionnaires 495 questionnaires were returned, 453 analyzed (completed within time lines)

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Quality of Life QLQ-C30 Scores

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-eloxatin-e2dbb09f
nct id
NCT01558921
qol key
qol-0005
source section id
NCT01558921-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'qlq' in the study's own wording
scale title
Quality of Life QLQ-C30 Scores
measure definition
Quality of life QLQ-C30 core questionnaire EORTC quality-of-life instrument for use in international clinical trials in oncology A total Quality of Life Questionnaire (QLQ) score can range from 0 to 88, higher score means worse outcome.
time frame
3 year after surgery
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher score means worse
population note
574 Patients without DrTF at 3 years post surgery were eligible to receive the questionnaires 495 questionnaires were returned, 453 analyzed (completed within time lines)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-QLQ-CIPN20)

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-eloxatin-e2dbb09f
nct id
NCT01558921
qol key
qol-0006
source section id
NCT01558921-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-QLQ-CIPN20)
measure definition
Quality of life EORTC-QLQ-CIPN20. International EORTC questionnaire to assess Chemotherapy-Induced Peripheral Neuropathy (CIPN). A total QLQ-CIPN20 score can range from 0 to 100, higher score means worse outcome. Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and compromised quality of life.
time frame
3 year after surgery
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher score means worse
population note
574 Patients without DrTF at 3 years post surgery were eligible to receive the questionnaires 495 questionnaires were returned, 453 analyzed (completed within time lines)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life LARS Scores

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-eloxatin-e2dbb09f
nct id
NCT01558921
qol key
qol-0007
source section id
NCT01558921-om-0007
source outcome index
7
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life LARS Scores
measure definition
Low Anterior Resection Syndrome (LARS) scores in patients without a stoma three years after curative surgery Patient reported score (5 questions). 0-12 no LARS, 21-29 Minor LARS, 30-42 Major LARS. Higher scores mean a worse outcome.
time frame
3 year after surgery
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
Higher scores mean a worse
population note
patients without a stoma three years after curative surgery
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-eloxatin-e2dbb09f
nct id
NCT01558921
trial label
Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0000
    source section id
    NCT01558921-om-0000
    source outcome index
    0
    endpoint
    Number of Patients With Disease Related Treatment Failure (DrTF)
    endpoint definition
    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.
    time origin
    3 years follow-up after surgery
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    462+450 participants started were eligible 2 + 6 participants were ineligible or withdrew informed consent
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0001
    source section id
    NCT01558921-om-0001
    source outcome index
    1
    endpoint
    Number of Patients Completing the Prescribe Neo-adjuvant Treatment Dose
    endpoint definition
    Number of patients in the experimental arm receiving 5 fractions of x 5 Gy (5x5Gy) radiotherapy followed by at least 75% of the prescribed chemotherapy. In the standard arm receiving the prescribed chemoradiotherapy.
    time origin
    30 days after neoadjuvant treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    901 of the 920 patients were evaluable
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0002
    source section id
    NCT01558921-om-0002
    source outcome index
    2
    endpoint
    Number of Patients With Negative CRM Negative
    endpoint definition
    Number of patients with a Circumferential Resection Margin (CRM) \> 1 mm
    time origin
    30 days after surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with a resection within 6 months after the end of preoperative treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0003
    source section id
    NCT01558921-om-0003
    source outcome index
    3
    endpoint
    Number of Patients With a Pathological Complete Response (pCR)
    endpoint definition
    Number of patients with a Pathological Complete Response (pCR) after neo-adjuvant treatment
    time origin
    30 days after surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with a resection within 6 months after the end of preoperative treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0004
    source section id
    NCT01558921-om-0004
    source outcome index
    4
    endpoint
    Number of Patients With Surgical Complications
    endpoint definition
    Number of patients with surgical complications: wound rupture, bleeding, infection, rectal anastomotic leak
    time origin
    30 days after surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients undergoing standard surgery with curative intention
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0005
    source section id
    NCT01558921-om-0005
    source outcome index
    5
    endpoint
    Quality of Life QLQ-C30 Scores
    endpoint definition
    Quality of life QLQ-C30 core questionnaire EORTC quality-of-life instrument for use in international clinical trials in oncology A total Quality of Life Questionnaire (QLQ) score can range from 0 to 88, higher score means worse outcome.
    time origin
    3 year after surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    574 Patients without DrTF at 3 years post surgery were eligible to receive the questionnaires 495 questionnaires were returned, 453 analyzed (completed within time lines)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0000
    arm key
    OG000
    arm label
    B: 5x5Gy -> CAPOX -> Surgery
    regimen
    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
    analyzed count
    462
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0000
    arm key
    OG001
    arm label
    A: 5 Weeks Chemoradiation -> Surgery
    regimen
    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.
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0001
    arm key
    OG000
    arm label
    B: 5x5Gy -> CAPOX -> Surgery
    regimen
    Experimental group B: 5x5Gy -\> CAPOX -\> Surgery
    analyzed count
    460
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0001
    arm key
    OG001
    arm label
    A: 5 Weeks Chemoradiation -> Surgery
    regimen
    Control group A: 5 Weeks Chemoradiation -\> Surgery
    analyzed count
    441
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0002
    arm key
    OG000
    arm label
    B: 5x5Gy -> CAPOX -> Surgery
    regimen
    Experimental group B: 5x5Gy -\> CAPOX -\> Surgery
    analyzed count
    423
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0002
    arm key
    OG001
    arm label
    A: 5 Weeks Chemoradiation -> Surgery
    regimen
    Control group A: 5 Weeks Chemoradiation -\> Surgery
    analyzed count
    398
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0003
    arm key
    OG000
    arm label
    B: 5x5Gy -> CAPOX -> Surgery
    regimen
    Experimental group B: 5x5Gy -\> CAPOX -\> Surgery
    analyzed count
    423
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0003
    arm key
    OG001
    arm label
    A: 5 Weeks Chemoradiation -> Surgery
    regimen
    Control group A: 5 Weeks Chemoradiation -\> Surgery
    analyzed count
    398
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0004
    arm key
    OG000
    arm label
    B: 5x5Gy -> CAPOX -> Surgery
    regimen
    Experimental group B: 5x5Gy -\> CAPOX -\> Surgery
    analyzed count
    426
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0004
    arm key
    OG001
    arm label
    A: 5 Weeks Chemoradiation -> Surgery
    regimen
    Control group A: 5 Weeks Chemoradiation -\> Surgery
    analyzed count
    400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Experimental Group
    regimen
    Experimental group B: 5x5Gy -\> CAPOX -\> Surgery
    analyzed count
    243
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Standard of Care Group With Post-operative Chemotherapy
    regimen
    Standard of care group with post-operative chemotherapy Chemoradiation -\> surgery -\> CAPOX
    analyzed count
    99
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01558921-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    harm key
    EG000
    source section id
    NCT01558921-ae
    event group key
    EG000
    event group label
    B: 5x5Gy -> CAPOX -> Surgery
    serious affected
    31
    serious at risk
    460
    other affected
    429
    other at risk
    460
    frequency threshold
    0
    collection period
    3 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    harm key
    EG001
    source section id
    NCT01558921-ae
    event group key
    EG001
    event group label
    A: 5 Weeks Chemoradiation -> Surgery
    serious affected
    13
    serious at risk
    441
    other affected
    421
    other at risk
    441
    frequency threshold
    0
    collection period
    3 years
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    qol key
    qol-0005
    source section id
    NCT01558921-om-0005
    source outcome index
    5
    instrument
    EORTC QLQ
    instrument basis
    matched 'qlq' in the study's own wording
    scale title
    Quality of Life QLQ-C30 Scores
    measure definition
    Quality of life QLQ-C30 core questionnaire EORTC quality-of-life instrument for use in international clinical trials in oncology A total Quality of Life Questionnaire (QLQ) score can range from 0 to 88, higher score means worse outcome.
    time frame
    3 year after surgery
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher score means worse
    population note
    574 Patients without DrTF at 3 years post surgery were eligible to receive the questionnaires 495 questionnaires were returned, 453 analyzed (completed within time lines)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    qol key
    qol-0006
    source section id
    NCT01558921-om-0006
    source outcome index
    6
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-QLQ-CIPN20)
    measure definition
    Quality of life EORTC-QLQ-CIPN20. International EORTC questionnaire to assess Chemotherapy-Induced Peripheral Neuropathy (CIPN). A total QLQ-CIPN20 score can range from 0 to 100, higher score means worse outcome. Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and compromised quality of life.
    time frame
    3 year after surgery
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher score means worse
    population note
    574 Patients without DrTF at 3 years post surgery were eligible to receive the questionnaires 495 questionnaires were returned, 453 analyzed (completed within time lines)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-eloxatin-e2dbb09f
    nct id
    NCT01558921
    qol key
    qol-0007
    source section id
    NCT01558921-om-0007
    source outcome index
    7
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life LARS Scores
    measure definition
    Low Anterior Resection Syndrome (LARS) scores in patients without a stoma three years after curative surgery Patient reported score (5 questions). 0-12 no LARS, 21-29 Minor LARS, 30-42 Major LARS. Higher scores mean a worse outcome.
    time frame
    3 year after surgery
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    Higher scores mean a worse
    population note
    patients without a stoma three years after curative surgery
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice