Laryngeal Preservation in Pyriform Sinus Carcinoma
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
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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-
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Aix Les Bains, France
- CALLOC'H
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Le Puy, France
- LITAS
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Lyon, France, 69000
- PIGNAT
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Montbrison, France
- MAYAUD
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Montpellier, France
- Crampette
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Nîmes, France
- Lallemant
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Roanne, France
- LACHEB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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
Investigators
- Principal Investigator: Jean-Michel PRADES, Pr, CHU de Saint-Étienne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0201089
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