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Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms

Thank you

Trial Information

Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).


Inclusion Criteria:



- Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or
larynx) but without evident metastasis.

- Inoperable tumor after revision by a multidisciplinary oncology team.

- Proved epidermoid carcinoma.

- ECOG = 0-1

- Good hematologic function (i.e, hemoglobin > 10 g/dl, ...)

- Good hepatologic function

- Good renal function

Exclusion Criteria:

- Pregnant or breast-feeding women. Potential child-bearing women should use an
effective conceptive method and should have a negative pregnancy test at least the
week before entering the study.

- Nasopharynx, nasal cavity and paranasal sinusitis will be excluded

- Previous chemotherapeutic or radiotherapeutic treatment for this disease.

- Previous or current neoplasms in other locations, except in situ cervicouterine
cancer properly treated or basal cell or squamous cell carcinoma

- Symptomatic peripheral neuropathy

- Other clinical severe diseases

- Concomitant treatment with corticoids within 6 months prior to inclusion.

- Concomitant treatment with any other neoplastic therapy

- Previous treatment for current disease.

- Loss of weight greater than 10% within the last 3 months.

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

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:

Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C).

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

JOSÉ Mª TABOADA

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Spain: Spanish Agency of Medicines

Study ID:

XRP6976F_2503

NCT ID:

NCT00261703

Start Date:

December 2002

Completion Date:

July 2010

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

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