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

NCT00827671 | Terminated Phase 2 DMC

• 2 other identifiers: NL23124.041.082008-002203-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

• pathological complete remission

  determination of tumor residual cell content in surgical specimen

  1 month

• Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment

  6 months

Secondary Outcomes (5)

• Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0

  5 months

• Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures

  4 weeks

• Progression free survival and overall survival

  5 years

• Define local (locoregional lymphnode metastasis as defined by TNM classification/ malignant peritonitis/ solid masses within the anatomic region of the esophagus) vs distant metastases as first manifestation of recurrence

  5 years

• The number of R0 resection determined by the pathologist

  after surgery

Study Arms (1)

Pre-operative chemotherapy

OTHER

Drug: cetuximab; Radiation: radiotherapy to oesophageal tumour

Interventions

cetuximab 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

Also known as: erbitux, c225

Pre-operative chemotherapy

radiotherapy to oesophageal tumour RADIATION

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

Pre-operative chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• P.O. Witteveen: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, 3584CX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 24335595 DERIVED

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• M. P. Lolkema, MD/PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

NL (1)