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NCT00265941 · OUTCOME

2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2022-06-14

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to 2 years

What was measured

Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy.

Analysis population: Randomized eligible N2-3 patients with follow-up and PET data

Groups in this outcome

Clinical CR + Negative PET

Clinical nodal complete response; negative post-treatment PET/CT scan

No Clinical CR + Negative PET

Did not have clinical nodal complete response; negative post-treatment PET/CT scan

Clinical CR + Positive PET

Clinical nodal complete response; positive post-treatment PET/CT scan

No Clinical CR + Positive PET

No clinical nodal complete response; positive post-treatment PET/CT scan

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

Analysis denominator · Participants

GroupSource count
Clinical CR + Negative PET26
No Clinical CR + Negative PET15
Clinical CR + Positive PET12
No Clinical CR + Positive PET9

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Clinical CR + Negative PET3.9Not reported011.4Not reported
No Clinical CR + Negative PET33.3Not reported8.458.3Not reported
Clinical CR + Positive PET16.7Not reported038.8Not reported
No Clinical CR + Positive PET11.1Not reported033.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        11.4
        value
        3.9
      2. group Id
        OG001
        lower Limit
        8.4
        upper Limit
        58.3
        value
        33.3
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        38.8
        value
        16.7
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        33.1
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      9
    units
    Participants
description
Patients are grouped by the combination of clinical nodal response status and the post-treatment PET/CT finding (negative or positive). Nodal relapse rate is calculated for each group by the cumulative incidence method. Relapse is defined as reappearance of tumor after complete response. If possible, relapse should be confirmed by biopsy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Clinical nodal complete response; negative post-treatment PET/CT scan
    id
    OG000
    title
    Clinical CR + Negative PET
  2. description
    Did not have clinical nodal complete response; negative post-treatment PET/CT scan
    id
    OG001
    title
    No Clinical CR + Negative PET
  3. description
    Clinical nodal complete response; positive post-treatment PET/CT scan
    id
    OG002
    title
    Clinical CR + Positive PET
  4. description
    No clinical nodal complete response; positive post-treatment PET/CT scan
    id
    OG003
    title
    No Clinical CR + Positive PET
param Type
NUMBER
population Description
Randomized eligible N2-3 patients with follow-up and PET data
reporting Status
POSTED
time Frame
From randomization to 2 years
title
2-year Nodal Relapse Rates in Clinical N2-3 Patients by Post-treatment PET/CT Finding and Nodal Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice