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NCT01185171 · OUTCOME

4 Year Disease Specific Survival

Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer · Source last updated 2023-05-11

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
0.3 to 4.7 years

What was measured

Percentage of patients who did not die by the disease within 4 years

Groups in this outcome

ZD1839 500mg by Mouth (po) Daily

Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.

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

Analysis denominator · Participants

GroupSource count
ZD1839 500mg by Mouth (po) Daily69

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ZD1839 500mg by Mouth (po) Daily89Not reported7795Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77
        upper Limit
        95
        value
        89
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    units
    Participants
description
Percentage of patients who did not die by the disease within 4 years
dispersion Type
95% Confidence Interval
groups
  1. description
    Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
    id
    OG000
    title
    ZD1839 500mg by Mouth (po) Daily
param Type
NUMBER
reporting Status
POSTED
time Frame
0.3 to 4.7 years
title
4 Year Disease Specific Survival
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice