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NCT02065687 · OUTCOME

Level of Obesity

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer · Source last updated 2021-09-30

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

Measure
NUMBER
Unit
proportion of participants obese
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model.

Analysis population: All patients

Groups in this outcome

Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)

Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Paclitaxel, Carboplatin, Placebo)

Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. 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 I (Paclitaxel, Carboplatin, Metformin Hydrochloride)234
Arm II (Paclitaxel, Carboplatin, Placebo)235

Reported measurements

Source class 1
Values in proportion of participants obese · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)0.4957Not reportedNot reportedNot reportedNot reported
Arm II (Paclitaxel, Carboplatin, Placebo)0.4979Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.27472
    group Description
    The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).
    non Inferiority Type
    EQUIVALENCE
    p Value
    0.9482
    param Type
    Cox Proportional Hazard
    param Value
    -0.01787
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.27472
    group Description
    The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).
    non Inferiority Type
    EQUIVALENCE
    p Value
    0.9482
    param Type
    Cox Proportional Hazard
    param Value
    -0.01787
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4957
      2. group Id
        OG001
        value
        0.4979
denoms
  1. counts
    1. group Id
      OG000
      value
      234
    2. group Id
      OG001
      value
      235
    units
    Participants
description
Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model.
groups
  1. description
    Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
  2. description
    Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm II (Paclitaxel, Carboplatin, Placebo)
param Type
NUMBER
population Description
All patients
reporting Status
POSTED
time Frame
Up to 5 years
title
Level of Obesity
type
SECONDARY
unit Of Measure
proportion of participants obese

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Preserved source evidence · Not medical advice