Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00851877 · OUTCOME

Phase II 2-year Progression-free Survival

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

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, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.

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 Radiotherapy60Not reported4278Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42
        upper Limit
        78
        value
        60
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
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, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.
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 Progression-free Survival
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice