Laryngeal Preservation in Pyriform Sinus Carcinoma

October 9, 2008 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix Les Bains, France
        • CALLOC'H
      • Le Puy, France
        • LITAS
      • Lyon, France, 69000
        • PIGNAT
      • Montbrison, France
        • MAYAUD
      • Montpellier, France
        • Crampette
      • Nîmes, France
        • Lallemant
      • Roanne, France
        • LACHEB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cisplatin was administered intravenously at a dose of 100 mg/m2 on day 1 and fluorouracil was administered at a dose of 1 000 mg/m2/day by continuous intravenous infusion on day 1 to 5 for 2 courses after 3 weeks. After induction chemotherapy patients underwent ears, nose and throat examination and computed tomography imaging.
Procedure: induction chemotherapy
Cisplatin was administered intravenously at a dose of 100 mg/m2 on day 1 and fluorouracil was administered at a dose of 1 000 mg/m2/day by continuous intravenous infusion on day 1 to 5 for 2 courses after 3 weeks. After induction chemotherapy patients underwent ears, nose and throat examination and computed tomography imaging. If a complete response (CR) or partial response (PR) of more than 80% is identified in the primary tumor, the patient was offered conventional radiotherapy as part of the protocol treatment. Radiotherapy was administered in 35 fractions of 2 Gy each over a 7 weeks period to the primary tumor (50 Gy) and the neck lymph nodes. The dose to the pathologically positive nodes was supplemented (20 Gy) at a total dose of 70 Gy. Doses and schedules of radiotherapy were identical in both treatment arms of the study.
Active Comparator: 2
Intravenous cisplatin at dose of 100 mg/m2 on days 1, 22 and 43 was administered concomitantly with conventional radiotherapy to the primary tumor and to the neck lymph nodes according to the pathological findings of the pre-treatment neck dissection at a total dose of 70 Gy.
Procedure: Conventionnal chemotherapy

Intravenous cisplatin at dose of 100 mg/m2 on days 1, 22 and 43 was administered concomitantly with conventional radiotherapy to the primary tumor and to the neck lymph nodes according to the pathological findings of the pre-treatment neck dissection at a total dose of 70 Gy.

- Surgery was recommended to all patients who had a response less than 80%, stable disease or progressive disease in the primary tumor. If surgery was not feasible, the treatment choice was left up to the investigator's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point was to compare the two treatment arms to define the best schedule of preservation of an intact larynx.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary end points analyzed causes of death, overall survival rate and event (loco-regional recurrent disease, metastases, death) free survival rate.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Jean-Michel PRADES, Pr, CHU DE SAINT-ETIENNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

October 10, 2008

Last Update Submitted That Met QC Criteria

October 9, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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