Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02126969 · OUTCOME

Overall Response Rate

A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN · Source last updated 2023-03-13

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 50 days

What was measured

To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT. Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): \> 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). (Note: the appearance of one or more new lesions is also considered progression).

Groups in this outcome

Chemotherapy Plus Radiation Therapy

Low dose fractionated radiation - 80cGy with chemotherapy Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT

Chemotherapy Without Radiation

Chemotherapy only Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation

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

Analysis denominator · Participants

GroupSource count
Chemotherapy Plus Radiation Therapy22
Chemotherapy Without Radiation20

Reported measurements

Source class 1

Overall Complete Response Rate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy Plus Radiation Therapy1Not reportedNot reportedNot reportedNot reported
Chemotherapy Without Radiation1Not reportedNot reportedNot reportedNot reported

Overall Partial Response Rate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy Plus Radiation Therapy11Not reportedNot reportedNot reportedNot reported
Chemotherapy Without Radiation12Not reportedNot reportedNot reportedNot reported

Overall Stable Disease Rate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy Plus Radiation Therapy10Not reportedNot reportedNot reportedNot reported
Chemotherapy Without Radiation7Not reportedNot reportedNot reportedNot reported

overall Progressive Disease Rate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy Plus Radiation Therapy0Not reportedNot reportedNot reportedNot reported
Chemotherapy Without Radiation0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      title
      Overall Complete Response Rate
    2. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        12
      title
      Overall Partial Response Rate
    3. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        7
      title
      Overall Stable Disease Rate
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      overall Progressive Disease Rate
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      20
    units
    Participants
description
To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT. Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): \> 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). (Note: the appearance of one or more new lesions is also considered progression).
groups
  1. description
    Low dose fractionated radiation - 80cGy with chemotherapy Low dose fractionated radiation - 80cGy with chemotherapy: Chemotherapy + 80 cGy of RT
    id
    OG000
    title
    Chemotherapy Plus Radiation Therapy
  2. description
    Chemotherapy only Docetaxel and Carboplatin AUC 6: Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
    id
    OG001
    title
    Chemotherapy Without Radiation
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 50 days
title
Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice