Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck

NCT02061631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-10-08

No results posted yet for this study

Summary

Primary Objective:

To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Secondary Objective:

To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Cisplatin

Pharmaceutical form:solution Route of administration: intravenous

DRUG

DOCETAXEL XRP6976

Pharmaceutical form:solution Route of administration: intravenous

DRUG

Dexamethasone

Pharmaceutical form:tablet Route of administration: oral

DRUG

Dexamethasone

Pharmaceutical form:solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2015-10-31

Countries

  • Pakistan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061631 on ClinicalTrials.gov