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NCT03943667 · STUDY IN CONTEXT

Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma

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

Time from the date of randomization to the date of death from any cause

Source null

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-metastatic-aecf3979
nct id
NCT03943667
trial label
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
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
1
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT03943667
    outcome key
    om-0000
    source section id
    NCT03943667-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Time from the date of randomization to the date of death from any cause
    time origin
    Until death (life expectancy around 12 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT03943667
    outcome key
    om-0000
    arm key
    OG000
    arm label
    GEMPAX
    regimen
    Gemcitabine + Paclitaxel until progression Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest. Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
    analyzed count
    140
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03943667-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT03943667
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Control
    regimen
    Gemcitabine alone until progression Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03943667-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT03943667
    harm key
    EG000
    source section id
    NCT03943667-ae
    event group key
    EG000
    event group label
    GEMPAX
    serious affected
    71
    serious at risk
    140
    other affected
    138
    other at risk
    140
    frequency threshold
    0
    collection period
    GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
    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-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT03943667
    harm key
    EG001
    source section id
    NCT03943667-ae
    event group key
    EG001
    event group label
    Control
    serious affected
    26
    serious at risk
    71
    other affected
    22
    other at risk
    71
    frequency threshold
    0
    collection period
    GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
    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
    setting source links

      Preserved source evidence · Not medical advice