Laryngeal Preservation in Pyriform Sinus Carcinoma - Full Text View

Sponsored by:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00770393

Purpose

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.

Condition	Intervention	Phase
Squamous Cell Carcinoma	Procedure: induction chemotherapy Procedure: Conventionnal chemotherapy	Phase II Phase III

Drug Information available for: Cisplatin Fluorouracil Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	71
Study Start Date:	February 2002
Study Completion Date:	June 2007
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

Arms

Assigned Interventions

1: Experimental

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.

2: Active Comparator

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.

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770393

Locations

France
PIGNAT
LYON, France, 69000
CRAMPETTE
Montpellier, France
LALLEMANT
Nîmes, France
CALLOC'H
AIX LES BAINS, France
LACHEB
ROANNE, France
LITAS
LE PUY, France
MAYAUD
MONTBRISON, France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator:

Jean-Michel PRADES, Pr

CHU de SAINT-ETIENNE

More Information

Responsible Party:	CHU de SAINT-ETIENNE ( Pr Jean-Michel PRADES )
Study ID Numbers:	0201089
Study First Received:	October 9, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00770393
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

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

Study placed in the following topic categories:

Epidermoid carcinoma
Cisplatin
Fluorouracil
Squamous cell carcinoma
Carcinoma, squamous cell

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009