Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial

An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Drug: DOCETAXEL; Drug: CISPLATIN; Drug: 5-FLUOROURACIL

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Sanofi Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Tumor type: Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) presenting with locally advanced disease at diagnosis. Primary tumor sites eligible are: oral cavity, oropharynx, hypopharynx and larynx.

• Extent of the disease:

  • Patients are required to have at least one measurable lesion.
  • Stage III or IV without evidence of distant metastases, according to the TNM staging system. Absence of metastases must be checked by chest X-ray (with or without Computed tomography (CT) ), abdominal ultrasound or CT in case of liver function test abnormalities, and bone scan in case of local symptoms.
  • Tumor considered as inoperable after evaluation by a multidisciplinary team. Reason for inoperability will be reported in the CRF
• World Health Organization (WHO) performance status 0 or 1

• Laboratory data:

  • Haematology:
• Neutrophil count > or = 2.0*10^9/L
• Platelet count > or = 100*10^9/L

• Hemoglobin > or = 10 g/dl (6.2 mmol/L)

  • Hepatic function:
• Total serum bilirubin < or = 1 time the upper normal limit (UNL) of the participating center
• Aspartate transaminase (ASAT/SGOT) and Alanine transaminase (ALAT/SGPT) < or = 2.5UNL
• Alkaline phosphatase < or = 5 UNL

• Patients with ASAT or ALAT > 1.5UNL associated with alkaline phosphatase >2.5UNL are not eligible for the study

  • Renal function:
• serum creatinine < or = 120µmol/L (1.4 mg/dl) if values are >120µmol/L, creatinine clearance should be > or = 60 ml/min
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, those conditions should be discussed with the patient before registration in the trial
• Patients informed consent form obtained

Exclusion criteria:

• Tumors of the nasopharynx, the nasal and paranasal cavities.
• Previous chemotherapy or radiotherapy for any reason and previous surgery for SCCHN at time of study entry.
• Prior treatment within a therapeutic clinical tria within 30 days prior to study entry
• Concurrent treatment with any other anticancer therapy
• Chronic treatment (> or = 3 months) with corticosteroids at a daily dose > or = 20mg methylprednisolone or equivalent.
• Concomitant use of drugs which could interact with 5-fluorouracil (e.g. cimetidine, allopurinol, folic or folinic acid, methotrexate and metronidazole)
• Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years
• Symptomatic peripheral neuropathy > or = grade 2 by NCIC-CTG criteria
• Clinical altered hearing
• Pregnant, lactating women or of childbearing potential unless adequate

• with other serious illness or medical condition including but not limited to:

  • unstable cardiac disease despite treatment
  • myocardial infarction within 6 months prior to study entry
  • history of significant neurologic or psychiatric disorders including dementia or seizures
  • active uncontrolled infection
  • active peptic ulcer
  • chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxel Cisplatin 5-Fluorouracil (DCF); 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): Docetaxel 60mg/m² on day 1; Cisplatin 75mg/m² on day 1; 5-FU 750mg/m²/day on day 1 to day 5	Drug: DOCETAXEL; Intravenous; Drug: CISPLATIN; Intravenous; Drug: 5-FLUOROURACIL; Intravenous
Experimental: Cisplatin 5-Fluorouracil (CF); 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): Cisplatin 75mg/m² on day 1; 5-FU 750mg/m²/day on day 1 to day 5	Drug: CISPLATIN; Intravenous; Drug: 5-FLUOROURACIL; Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	From randomization to patient death (follow-up every 3 months 1st year, then every 6 months)
Overall response rates	From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy
Duration of response	From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
Time to treatment failure	From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Mo Chen, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2009
• Primary Completion (Actual): January 26, 2018
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Fluorouracil
• Other Study ID Numbers: DOCET_L_02557