Know Cancer

or
forgot password

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


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Both
Squamous Cell Carcinoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Jean-Michel PRADES, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de SAINT-ETIENNE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0201089

NCT ID:

NCT00770393

Start Date:

February 2002

Completion Date:

June 2007

Related Keywords:

  • Squamous Cell Carcinoma
  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell

Name

Location