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Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma


Phase 3
18 Years
75 Years
Not Enrolling
Both
Larynx Cancer, Hypopharynx Cancer

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Trial Information

Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma


The purpose of the study is to compare two regimen of induction chemotherapy for patients
with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total
laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU)
versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment
are treated with radiation with a purpose of larynx preservation. Non responders patients
will be treated with total laryngectomy followed by postoperative radiation.


Inclusion Criteria:



- T3 and T4 larynx and hypopharynx tumor that would be treated with total laryngectomy

- Biopsy proven carcinoma

- Adequate biology

- Performance status 0 or 1

Exclusion Criteria:

- Larynx or hypopharynx tumors that could be treated with partial laryngectomy

- Distant metastasis

- Prior surgery, chemotherapy or radiation

- Intercurrent disease that is a contra indication to chemotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

3-years larynx preservation rate

Principal Investigator

Gilles Calais, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Bretonneau

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GORTEC 2000-01

NCT ID:

NCT00169182

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Larynx Cancer
  • Hypopharynx Cancer
  • Larynx cancer
  • Hypopharynx cancer
  • Chemotherapy
  • Randomized trial
  • Larynx preservation
  • Carcinoma
  • Laryngeal Neoplasms
  • Laryngeal Diseases
  • Hypopharyngeal Neoplasms

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