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NCT00087698 · OUTCOME

Overall Tumor Response

Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma · Source last updated 2009-05-12

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
baseline to measured progressive disease

What was measured

The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.

Analysis population: Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.

Groups in this outcome

Pemetrexed

pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

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

Analysis denominator · Participants

GroupSource count
Pemetrexed77

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed1Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed24Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed36Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed5Not reportedNot reportedNot reportedNot reported
Unknown/Unavailable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        36
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Unknown/Unavailable
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    units
    Participants
description
The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
groups
  1. description
    pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
    id
    OG000
    title
    Pemetrexed
param Type
NUMBER
population Description
Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.
reporting Status
POSTED
time Frame
baseline to measured progressive disease
title
Overall Tumor Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice