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CompletedNCT00521521TAX200006Updated Dec 7, 2009

Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

A Phase 2 interventional study of docetaxel and cisplatin and docetaxel in Head and Neck Neoplasms, sponsored by Sanofi. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-12-07.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).

02

Conditions studied

  • Head and Neck Neoplasms
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 86 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
  • Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
  • Age ≥ 18 years and ≤ 70 years.
  • PS \< 2.
  • Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.

Exclusion criteria

Exclusion Criteria:

  • Any metastases (other than cervical ganglia).
  • Cancer of the cavum and the facial structure.
  • Any previous chemotherapy or radiotherapy, irrespective of the reason.
  • Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
  • Weight loss ≥10% of total body weight during the last 3 months.
  • Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular).
  • Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception.
  • Poorly controlled progressive infection.
  • Peripheral neuropathy with NCI grade ≥ 2.
  • Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.
  • Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
  • Any other concomitant investigational treatment.
  • Any other concomitant anticancer treatment.
  • Allergy to polysorbate 80.
  • Definitive formal contraindication to corticosteroids.

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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Active comparator
    docetaxel and cisplatin

    Drug: docetaxel and cisplatin

  • Experimental
    docetaxel

    Drug: docetaxel

Interventions

  • Drugdocetaxel and cisplatin
  • Drugdocetaxel
06

What researchers measure

Primary outcomes

  1. Objective response rates

    Time frame: evaluated 8 weeks after the end of radiotherapy

Secondary outcomes

  1. Duration of the responses and overall survival

    Time frame: time until progression

07

Study locations

1 site
  • Sanofi-Aventis
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00521521
Lead sponsor
Sanofi
First posted
Aug 28, 2007
Start date
Jul 2001
Primary completion
May 2006
Last update
Dec 7, 2009

Study contacts

Marie SEBILLE, Dr.
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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