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

P.O. Witteveen

Status and phase

Terminated

Phase 2

Conditions

Resectable Esophageal Cancer

Treatments

Drug: cetuximab

Radiation: radiotherapy to oesophageal tumour

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00827671

2008-002203-13 (EudraCT Number)

NL23124.041.08

Details and patient eligibility

About

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.

Full description

This study aims at developing a novel strategy to optimize the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. Surgery in combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin and 5-FU, as defined by the recent MAGIC trial, results in 13% increase in 5-yr survival. To improve the outcome of patients with this disease we hypothesize that the addition of pre-operative combined cetuximab-radiotherapy (cetux-RT) treatment could improve the outcome of this patient category through better local control.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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