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NCT00599131 · OUTCOME

Percentage of Patients Achieving Histologic Complete Response

Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE) · Source last updated 2015-12-03

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
3 years

What was measured

The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.

Analysis population: The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.

Groups in this outcome

Chemotherapy/Radiation/Surgery

Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.

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/Radiation/Surgery0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.
groups
  1. description
    Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4. On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2. Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
    id
    OG000
    title
    Chemotherapy/Radiation/Surgery
population Description
The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.
reporting Status
POSTED
time Frame
3 years
title
Percentage of Patients Achieving Histologic Complete Response
type
PRIMARY

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

Preserved source evidence · Not medical advice