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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827671
Recruitment Status : Terminated (Experimental treatment not feasible due to high rate of drop out)
First Posted : January 23, 2009
Last Update Posted : March 9, 2018
Merck KGaA
Information provided by (Responsible Party):
P.O. Witteveen, UMC Utrecht

January 22, 2009
January 23, 2009
March 9, 2018
March 2009
December 2015   (Final data collection date for primary outcome measure)
  • pathological complete remission [ Time Frame: 1 month ]
    determination of tumor residual cell content in surgical specimen
  • Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment [ Time Frame: 6 months ]
  • pathological complete remission [ Time Frame: after surgery ]
  • Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00827671 on Archive Site
  • Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0 [ Time Frame: 5 months ]
  • Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures [ Time Frame: 4 weeks ]
  • Progression free survival and overall survival [ Time Frame: 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 [ Time Frame: 5 years ]
  • The number of R0 resection determined by the pathologist [ Time Frame: after surgery ]
Same as current
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Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma
Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
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.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Resectable Esophageal Cancer
  • Drug: 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
    Other Names:
    • erbitux
    • c225
  • Radiation: radiotherapy to oesophageal tumour
    45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk
Pre-operative chemotherapy
  • Drug: cetuximab
  • Radiation: radiotherapy to oesophageal tumour
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2008-002203-13 ( EudraCT Number )
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P.O. Witteveen, UMC Utrecht
P.O. Witteveen
Merck KGaA
Principal Investigator: M. P. Lolkema, MD/PhD UMC Utrecht
UMC Utrecht
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP