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Laryngeal Preservation in Pyriform Sinus Carcinoma

Information source: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Squamous Cell Carcinoma

Intervention: induction chemotherapy (Procedure); Conventionnal chemotherapy (Procedure)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Centre Hospitalier Universitaire de Saint Etienne

Official(s) and/or principal investigator(s):
Jean-Michel PRADES, Pr, Principal Investigator, Affiliation: CHU de SAINT-ETIENNE

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.

Clinical Details

Official title: Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma

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

Primary outcome: The primary end point was to compare the two treatment arms to define the best schedule of preservation of an intact larynx.

Secondary outcome: Secondary end points analyzed causes of death, overall survival rate and event (loco-regional recurrent disease, metastases, death) free survival rate.

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

CALLOC'H, Aix Les Bains, France

LITAS, Le Puy, France

PIGNAT, Lyon 69000, France

MAYAUD, Montbrison, France

Crampette, Montpellier, France

Lallemant, Nîmes, France

LACHEB, Roanne, France

Additional Information

Starting date: February 2002
Last updated: October 9, 2008

Page last updated: August 23, 2015

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