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

NCT00995293 | Completed Phase 3

• 1 other identifier: DOCET_L_02557
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)

Secondary Outcomes (4)

• 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

Study Arms (2)

Docetaxel Cisplatin 5-Fluorouracil (DCF)

EXPERIMENTAL

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; Drug: CISPLATIN; Drug: 5-FLUOROURACIL

Cisplatin 5-Fluorouracil (CF)

EXPERIMENTAL

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; Drug: 5-FLUOROURACIL

Interventions

DOCETAXEL DRUG

Intravenous

Docetaxel Cisplatin 5-Fluorouracil (DCF)

CISPLATIN DRUG

Intravenous

Cisplatin 5-Fluorouracil (CF); Docetaxel Cisplatin 5-Fluorouracil (DCF)

5-FLUOROURACIL DRUG

Intravenous

Cisplatin 5-Fluorouracil (CF); Docetaxel Cisplatin 5-Fluorouracil (DCF)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi Administrative Office

Shanghai, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mo Chen

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: October 15, 2009
• Study Start: August 27, 2009
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-03

Locations

CN (1)