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

This study has been terminated.
(Experimental treatment not feasible due to high rate of drop out)
Sponsor:
Collaborator:
Merck KGaA
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00827671
First received: January 22, 2009
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Resectable Esophageal Cancer
Drug: cetuximab
Radiation: radiotherapy to oesophageal tumour
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • pathological complete remission [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0 [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Progression free survival and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The number of R0 resection determined by the pathologist [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827671

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

No publications provided

Responsible Party: Dr. M.P.J.K. Lolkema, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00827671     History of Changes
Other Study ID Numbers: NL23124.041.08, 2008-002203-13
Study First Received: January 22, 2009
Last Updated: October 25, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014