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NCT00851877 · OUTCOME

Phase II 2-year Local Control

Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer · Source last updated 2020-08-21

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
2 year

What was measured

Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions

Analysis population: 12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.

Groups in this outcome

Phase II Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation 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
Phase II Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy34

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy71Not reported5587Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55
        upper Limit
        87
        value
        71
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions
dispersion Type
95% Confidence Interval
groups
  1. description
    Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
    id
    OG000
    title
    Phase II Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy
param Type
NUMBER
population Description
12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.
reporting Status
POSTED
time Frame
2 year
title
Phase II 2-year Local Control
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice