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Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab

Phase 2
18 Years
Not Enrolling
Resectable Esophageal Cancer

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Trial Information

Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathological complete remission

Outcome Description:

determination of tumor residual cell content in surgical specimen

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

M. P. Lolkema, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

March 2009

Completion Date:

August 2010

Related Keywords:

  • Resectable Esophageal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms