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A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere®) Plus Cisplatin and 5-Fluorouracil (TPF) Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere®) Plus Cisplatin and 5-Fluorouracil (TPF) Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



- 1.Histologically or cytologically proven squamous cell carcinoma of the head/neck.

- 2.Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx, larynx.
Although they are admittedly of squamous cell types, the following tumors will be
excluded because their responsiveness to chemotherapy may differ: nasal, paranasal
cavities; nasopharynx.

- 3.Stage 3 or 4 disease without evidence of distant metastases verified with Chest
X-Ray, abdominal ultrasound or CT (liver function test abnormalities); bone scan in
case of local symptoms.

- 4.At least one uni or bidimensionally measurable lesion.

- 5.Tumor considered as inoperable after evaluation by a multidisciplinary team
(surgeon, medical oncologist and radiation oncologist). Criteria include : Technical
unresectablility-ie tumor fixation/invasion to base of the skull or cervical
vertebrae involvement of the nasopharynx and fixed lymph nodes; Physician's decision
based on low surgical curability which includes all T3-4 stages, all N2-3 stages
excluding T1N2; organ preservation.

- 6.No previous chemotherapy or radiotherapy for any reason and no previous surgery for
SCCHN (other than biopsy) are allowed at time of study entry.

- 7.Age ³ 18 years.

- 8.WHO performance status of 0-1

- 9.No active alcohol addiction

- 10.Life expectancy ³ 12 weeks

- 11.Signed informed consent prior to beginning protocol specific procedures

- 12.Adequate bone marrow, hepatic and renal functions as evidenced by the following:
Hematology (Bone Marrow): Neutrophil count ³ 2.0 x 10 9/L; Platelet count ³ 100 X 10
9/L; Hemoglobin ³ 10g/dL; Hepatic function : Total bilirubin WNL; ASAT (SGOT) and
ALAT (SGPT) £ 2.5 X ULN; Alkaline phosphatase £ 5 X ULN; patients with ASAT or ALAT >
1.5 x ULN associated with alkaline phosphatase > 2.5 x ULN are not eligible for the
study; Renal function: the creatinine clearance ³ 60 ml/min (actual or calculated by
the Cockcroft-Gault method as follows: Weight (kg) X (140-age)/K x serum creatinine.

- 13.Patients must be available for treatment and follow up. Patients registered on
this trial must be treated and followed at the participating center.

Exclusion Criteria:

- 1.Pregnant or lactating women or women of childbearing potential not using adequate
contraception.

- 2.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. Any prior treatment with radiotherapy or chemotherapy
is an exclusion criterion.

- 3.Symptomatic peripheral neuropathy ³ grade 2 by NCIC-CTG criteria.

- 4.Symptomatic altered hearing > grade 2 by NCIC-CTG criteria.

- 5.Other serious illnesses or medical conditions including but no 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;
Hypercalcemia; Chronic obstructive pulmonary disease requiring hospitalization during
the year preceding study entry.

- 6.Patients requiring intravenous alimentation.

- 7.Patients who experienced a weight loss of more than 20% of their body weight in the
3 months preceding study entry.

- 8.Concurrent treatment with any other anticancer therapy

- 9.Participation in an investigational trial within 30 days of study entry.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.

Principal Investigator

Marshall Posner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

EFC6043

NCT ID:

NCT00273546

Start Date:

May 1999

Completion Date:

February 2006

Related Keywords:

  • Cancer
  • Head and Neck Cancer
  • Induction
  • Chemotherapy
  • Chemoradiotherapy
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807