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NCT02126969 · OUTCOME

Primary Site Complete 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

Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined 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; Where possible, surgeon also evaluated primary site and provided response assessment.

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
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy Plus Radiation Therapy6Not reportedNot reportedNot reportedNot reported
Chemotherapy Without Radiation4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined 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; Where possible, surgeon also evaluated primary site and provided response assessment.
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
Primary Site Complete Response Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice