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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
P.O. Witteveen, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Resectable Esophageal Cancer Drug: cetuximab Radiation: radiotherapy to oesophageal tumour Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
Actual Study Start Date : March 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Pre-operative chemotherapy 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



Primary Outcome Measures :
  1. pathological complete remission [ Time Frame: 1 month ]
    determination of tumor residual cell content in surgical specimen

  2. Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0 [ Time Frame: 5 months ]
  2. Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures [ Time Frame: 4 weeks ]
  3. Progression free survival and overall survival [ Time Frame: 5 years ]
  4. 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 ]
  5. The number of R0 resection determined by the pathologist [ Time Frame: after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827671


Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
P.O. Witteveen
Merck KGaA
Investigators
Principal Investigator: M. P. Lolkema, MD/PhD UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: P.O. Witteveen, Head of Department, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00827671     History of Changes
Other Study ID Numbers: NL23124.041.08
2008-002203-13 ( EudraCT Number )
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cetuximab
Antineoplastic Agents