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NCT00566540 · OUTCOME

Percentage of Participants With Serious Adverse Events

Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer · Source last updated 2021-11-26

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to one year

What was measured

Determine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen.

Groups in this outcome

Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)

PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod

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

Analysis denominator · Participants

GroupSource count
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)11

Reported measurements

Leukocytes
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Rash
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Colitis
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Dehydration
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)18Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Vomiting
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Hemorrhage, Upper Respiratory
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Infection with normal ANC
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Edema
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Leukocytes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Rash
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Colitis
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Dehydration
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Vomiting
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Hemorrhage, Upper Respiratory
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Infection with normal ANC
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Edema
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Determine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen.
groups
  1. description
    PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod
    id
    OG000
    title
    Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to one year
title
Percentage of Participants With Serious Adverse Events
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice