Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Patients (SCCHNS)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00357149
First received: July 26, 2006
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.


Condition Intervention Phase
Head and Neck Neoplasms
Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy
Drug: Concomitant cisplatin, 5-FU and radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment [ Time Frame: from end of treatment until 6-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: from the date of first documented tumor response to the date of first documented tumor progression ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: From the date of the treatment start to the date of first documented progression of disease ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause ] [ Designated as safety issue: No ]
  • Median length of overall survival [ Time Frame: time interval from the date of treatment to the date of death ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: January 2003
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy.
Drug: Concomitant cisplatin, 5-FU and radiotherapy
Experimental: B
Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm).
Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck.
  • Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.
  • Stage III or IV disease without evidence of distant metastases verified by chest X Ray and/or lung CT scan, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
  • At least one measurable lesion.
  • Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist).
  • No previous chemotherapy or radiotherapy for any reason and no previous surgery for squamous cell carcinoma of the head and neck patients (other than biopsy) are allowed at time of study entry.
  • Karnofsky performance status ≥ 70.
  • No active alcohol addiction.
  • Adequate bone marrow, hepatic and renal functions
  • Patients must be available for treatment and follow-up.

Exclusion criteria

  • Pregnant or lactating women or women of childbearing potential not using adequate contraception.
  • 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 ≥ grade 2
  • Symptomatic altered hearing ≥ grade 2
  • Other serious illnesses or medical conditions including:a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) History of significant neurologic or psychiatric disorders including dementia or seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f) Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
  • History of hypersensitivity reaction to polysorbate 80
  • Patients requiring intravenous alimentation.
  • Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
  • Concomitant treatment with any other anticancer therapy.
  • Participation in a therapeutic clinical trial within 30 days of study entry

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357149

Locations
Italy
Sanofi-Aventis
Milan, Italy
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Georges Paizis, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00357149     History of Changes
Other Study ID Numbers: XRP6976F_2501
Study First Received: July 26, 2006
Last Updated: December 4, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014