Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

September 6, 2018

Study Completion Date

September 6, 2018

Conditions
Esophageal Cancer
Interventions
DRUG

Cetuximab

Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total

DRUG

Cisplatin, 5-FU

"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 of cycle 1 and 2, 750mg/m2/day as continuous infusion on day 1-4 of cycle 3 and 4~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle"

RADIATION

Radiotherapy

59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.

Trial Locations (1)

23538

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Strahlentherapie, Lübeck

All Listed Sponsors
lead

University Hospital Schleswig-Holstein

OTHER

NCT01787006 - Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer | Biotech Hunter | Biotech Hunter