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NCT02122185 · OUTCOME

Overall Survival

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2026-03-27

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
Up to 6 years

What was measured

Time from randomization to death.

Groups in this outcome

Metformin Plus Chemotherapy

Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.

Placebo Plus Chemotherapy

Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.

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

Analysis denominator · Participants

GroupSource count
Metformin Plus Chemotherapy54
Placebo Plus Chemotherapy54

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metformin Plus Chemotherapy40.7Not reported28.048.2Not reported
Placebo Plus Chemotherapy43.8Not reported35.357.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    96
    ci Upper Limit
    2.29
    estimate Comment
    Adjusted for initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.21
    p Value Comment
    Two-sided.
    param Type
    Hazard Ratio (HR)
    param Value
    1.49
    statistical Comment
    Stratified by initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    96
    ci Upper Limit
    2.29
    estimate Comment
    Adjusted for initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.21
    p Value Comment
    Two-sided.
    param Type
    Hazard Ratio (HR)
    param Value
    1.49
    statistical Comment
    Stratified by initial treatment (primary debulking surgery or neoadjuvant therapy followed by surgery) and planned chemotherapy regimen.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.0
        upper Limit
        48.2
        value
        40.7
      2. group Id
        OG001
        lower Limit
        35.3
        upper Limit
        57.2
        value
        43.8
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      54
    units
    Participants
description
Time from randomization to death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
    id
    OG000
    title
    Metformin Plus Chemotherapy
  2. description
    Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
    id
    OG001
    title
    Placebo Plus Chemotherapy
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 6 years
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice