Laryngeal Preservation in Pyriform Sinus Carcinoma

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

June 30, 2005

Study Completion Date

June 30, 2007

Conditions
Squamous Cell Carcinoma
Interventions
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."

Trial Locations (7)

69000

PIGNAT, Lyon

Unknown

CALLOC'H, Aix-les-Bains

LITAS, Le Puy

MAYAUD, Montbrison

Crampette, Montpellier

Lallemant, Nîmes

LACHEB, Roanne

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT00770393 - Laryngeal Preservation in Pyriform Sinus Carcinoma | Biotech Hunter | Biotech Hunter