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NCT04162873 · OUTCOME

Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo.

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer · Source last updated 2025-02-12

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 140 days

What was measured

This outcome will report the number of participants who missed treatment days during adjuvant radiation, who did not miss any treatment days during adjuvant radiation, and the number of participants who did not start adjuvant radiation therapy.

Analysis population: One participant on the Celecoxib Arm was not evaluable for this outcome measure.

Groups in this outcome

Celecoxib Arm

Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Placebo Arm

Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Celecoxib Arm4
Placebo Arm7

Reported measurements

No Adjuvant Radiation Therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Celecoxib Arm2Not reportedNot reportedNot reportedNot reported
Placebo Arm1Not reportedNot reportedNot reportedNot reported
No days of missed adjuvant radiation therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Celecoxib Arm2Not reportedNot reportedNot reportedNot reported
Placebo Arm5Not reportedNot reportedNot reportedNot reported
More than 0 days of adjuvant radiation therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Celecoxib Arm0Not reportedNot reportedNot reportedNot reported
Placebo Arm1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    No Adjuvant Radiation Therapy
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
    title
    No days of missed adjuvant radiation therapy
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    More than 0 days of adjuvant radiation therapy
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      7
    units
    Participants
description
This outcome will report the number of participants who missed treatment days during adjuvant radiation, who did not miss any treatment days during adjuvant radiation, and the number of participants who did not start adjuvant radiation therapy.
groups
  1. description
    Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    OG000
    title
    Celecoxib Arm
  2. description
    Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
    id
    OG001
    title
    Placebo Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
One participant on the Celecoxib Arm was not evaluable for this outcome measure.
reporting Status
POSTED
time Frame
up to 140 days
title
Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice