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NCT00566540 · OUTCOME

Feasibility of Treatment

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to one year

What was measured

Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy

Analysis population: The data was not collected or analyzed due to discontinuation of study in early stages.

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)0

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
Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy
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)
population Description
The data was not collected or analyzed due to discontinuation of study in early stages.
reporting Status
POSTED
time Frame
Up to one year
title
Feasibility of Treatment
type
PRIMARY

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

Preserved source evidence · Not medical advice