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

NCT ID: NCT00827671

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2016-03-31

Brief 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.

Detailed 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.

Conditions

Resectable Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-operative chemotherapy

Group Type: OTHER

cetuximab

Intervention Type: DRUG

cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment

radiotherapy to oesophageal tumour

Intervention Type: RADIATION

45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk

Interventions

cetuximab

cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment

Intervention Type: DRUG

radiotherapy to oesophageal tumour

45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk

Intervention Type: RADIATION

Other Intervention Names

erbitux; c225

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

P.O. Witteveen

OTHER

Sponsor Role: lead

Responsible Party

P.O. Witteveen

Head of Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

M. P. Lolkema, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

UMC Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

Ubink I, van der Sluis P, Schipper M, Reerink O, Voest E, Borel-Rinkes I, Wijrdeman H, Vleggaar F, Agterof M, Overkleeft E, Siersema P, van Hillegersberg R, Lolkema MP. Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a single-center prospective phase II trial. Oncologist. 2014 Jan;19(1):32-3. doi: 10.1634/theoncologist.2013-0254. Epub 2013 Dec 12.

Reference Type: DERIVED

PMID: 24335595 (View on PubMed)

Other Identifiers

2008-002203-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL23124.041.08

Identifier Type: -

Identifier Source: org_study_id