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NCT00608205 · OUTCOME

Patterns of Failure

Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2020-08-06

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
2 years from start of study

What was measured

Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.

Analysis population: intention to treat (ITT)

Groups in this outcome

Arm A

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Arm B

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

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 A35
Arm B34

Reported measurements

Local recurrence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A1Not reportedNot reportedNot reportedNot reported
Arm B1Not reportedNot reportedNot reportedNot reported
Regional (nodal) recurrence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A1Not reportedNot reportedNot reportedNot reported
Arm B0Not reportedNot reportedNot reportedNot reported
Distant recurrence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A4Not reportedNot reportedNot reportedNot reported
Arm B4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Local recurrence
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Regional (nodal) recurrence
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
    title
    Distant recurrence
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      34
    units
    Participants
description
Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
groups
  1. description
    Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
    id
    OG000
    title
    Arm A
  2. description
    Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
    id
    OG001
    title
    Arm B
param Type
NUMBER
population Description
intention to treat (ITT)
reporting Status
POSTED
time Frame
2 years from start of study
title
Patterns of Failure
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice