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NCT02595424 · OUTCOME

Overall Survival (OS)

Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas · Source last updated 2026-07-27

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
assessed at baseline, then every 3 months within 2 years from randomization, and every 6 months if patient is 3-5 years from randomization, up to 5 years from randomization

What was measured

OS is defined as the time from randomization to death from any cause. OS is censored at the date of last contact. Median OS is estimated using the Kaplan-Meier method.

Analysis population: All eligible patients

Groups in this outcome

Arm A (Capecitabine, Temozolomide)

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm B (Cisplatin, Carboplatin, Etoposide)

Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm A (Capecitabine, Temozolomide)31
Arm B (Cisplatin, Carboplatin, Etoposide)32

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Capecitabine, Temozolomide)12.6Not reported5.430.3Not reported
Arm B (Cisplatin, Carboplatin, Etoposide)10.8Not reported9.621.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.02
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.35
    param Type
    Cox Proportional Hazard
    param Value
    1.12
    statistical Comment
    stratified log rank test was used, stratifying the randomization factors (ECOG PS 0-1 vs ECOG PS 2; GI vs Pancreatic NET).
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.02
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.35
    param Type
    Cox Proportional Hazard
    param Value
    1.12
    statistical Comment
    stratified log rank test was used, stratifying the randomization factors (ECOG PS 0-1 vs ECOG PS 2; GI vs Pancreatic NET).
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        30.3
        value
        12.6
      2. group Id
        OG001
        lower Limit
        9.6
        upper Limit
        21.1
        value
        10.8
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      32
    units
    Participants
description
OS is defined as the time from randomization to death from any cause. OS is censored at the date of last contact. Median OS is estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm A (Capecitabine, Temozolomide)
  2. description
    Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm B (Cisplatin, Carboplatin, Etoposide)
param Type
MEDIAN
population Description
All eligible patients
reporting Status
POSTED
time Frame
assessed at baseline, then every 3 months within 2 years from randomization, and every 6 months if patient is 3-5 years from randomization, up to 5 years from randomization
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice