Laryngeal Preservation in Pyriform Sinus Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00770393
First received: October 9, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 9, 2008
October 9, 2008
February 2002
June 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Squamous Cell Carcinoma
  • 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.
  • 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.

  • 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.
    Intervention: Procedure: induction chemotherapy
  • 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.
    Intervention: Procedure: Conventionnal chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
June 2007
June 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00770393
0201089
No
Pr Jean-Michel PRADES, CHU de SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Jean-Michel PRADES, Pr CHU de SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP