NCT00733889

A Study to Evaluate the Combination of Cetuximab and Chemotherapy as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy Plus Cetuximab in Locoregional Esophageal Carcinoma

Phase II, Multicentre, Uncontrolled Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Chemotherapy (Docetaxel, Cisplatin, 5-fluorouracil) as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy (Cisplatin) Plus Cetuximab in Patients With a Locoregional Esophageal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)	Neoadjuvant chemotherapy plus cetuximab: 3 cycles of chemotherapy (Docetaxel: 75 mg/m2; day1; Cisplatin :75 mg/m2, day 1; 5-FU: 750 mg/m2; 24-hour infusion; day1-5) administered every 3 weeks, plus cetuximab (250 mg/m2; day 1, 8 and 15) Cetuximab will be maintained from the beginning of chemotherapy until the end of radiotherapy. Radio-chemotherapy plus cetuximab: The radiotherapy treatment: A dose of 50.4 Gy will be administered in 28 fractions of 1.8 Gy / day, 5 days a week (a total of 5.6 weeks). Cetuximab:250 mg/m2 and Cisplatin: 40 mg/m2, day 1, 8, 15, 22, 29 and 36

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2008-08-13
• Last updated: 2013-02-20

Locations

1 site across 1 country: Spain