Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: P.O. Witteveen; UMC Utrecht
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction

• Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.

• Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained.

• Weight loss < 10% in 0.5 yr

• WHO performance status 0-1

• No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus

Exclusion Criteria:

• Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ.

• Inadequate organ function as defined by:

• Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils < 1,5 109/L -platelets <100*109/L),

• Liver enzyme elevation (bili > 1,5*ULN - ASAT > 2,5*ULN - ALAT > 2,5*ULN) or

• Impaired renal function (creatinine clearance by cockcroft < 60 cc/min)

• Proteinuria >1,0gr/24hr

• Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially

• Major surgery within 4 weeks prior to the start of study treatment

• Bleeding disorder

• Known allergy to one of the study drugs used

• Use of any substance known to interfere with the chemotherapy clearance

• Previous radiotherapy to the chest

• Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments

• Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias

• Continuous use of immunosuppressive agents

• Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine

• Prior exposure to anti-EGFR targeting agents.

• Hearing loss > 25 dB under normal

• Neurotoxicity > CTC grade 1

• Pregnancy or breast feeding

• Patients (M/F) with reproductive potential not implementing adequate contraceptive measures