Clinical trial NCT00770393: Laryngeal Preservation in Pyriform Sinus Carcinoma
Official title: Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Squamous Cell Carcinoma
Keywords: squamous cell carcinoma of the pyriform sinus
laryngeal preservation
patients with biopsy-proven previously untreated resectable T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.

The study compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death and survival rates.

Detailed description: Objectives: To compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death and survival rates.

Design: Multicenter prospective randomized phase III trial. Setting: Academic tertiary care center. Patients: Seventy one adult patients with biopsy-proven previously untreated resectable T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.

Main Outcomes Measures: Patients were evaluated for toxic reactions, and organ preservation and survival rates. Statistical analysis of overall survival and event free survival was performed using the Kaplan Meier method.

Eligibility criteria: Inclusion Criteria:

* Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.

Patients also had to have a performance status (PS)\< 1, and normal organ functions as defined by an absolute neutrophil count \> 1500 cells/microl, platelet count \> 100 000 cells/microl and a calculated creatinine clearance of more than 50 ml/min.

Exclusion Criteria:

* Patients with T1, T2 or T4 or M1 (metastatic disease) were ineligible.

Primary outcomes:
measure: The primary end point was to compare the two treatment arms to define the best schedule of preservation of an intact larynx.
timeFrame: 2 years
Secondary outcomes:
measure: Secondary end points analyzed causes of death, overall survival rate and event (loco-regional recurrent disease, metastases, death) free survival rate.
timeFrame: 2 years
Other outcomes:
Locations:
city: Aix Les Bains
country: France
facility: CALLOC'H
city: Le Puy
country: France
facility: LITAS
city: Lyon
country: France
facility: PIGNAT
city: Montbrison
country: France
facility: MAYAUD
city: Montpellier
country: France
facility: Crampette
city: Nîmes
country: France
facility: Lallemant
city: Roanne
country: France
facility: LACHEB
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Jean-Michel PRADES, Pr
role: PRINCIPAL_INVESTIGATOR
References: