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NCT00352105 · OUTCOME

Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.

Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer · Source last updated 2012-11-05

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
3 years

What was measured

Complete response rate per RECIST Criteria (CTC V3)

Analysis population: 5 early deaths were not evaluable

Groups in this outcome

5-FU, Cisplatin, Radiation and Iressa

Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years 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
5-FU, Cisplatin, Radiation and Iressa55

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU, Cisplatin, Radiation and Iressa42Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Complete response rate per RECIST Criteria (CTC V3)
groups
  1. description
    Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    5-FU, Cisplatin, Radiation and Iressa
param Type
NUMBER
population Description
5 early deaths were not evaluable
reporting Status
POSTED
time Frame
3 years
title
Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice