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Clinical Trials/ISRCTN47718479
ISRCTN47718479
Completed
Phase 2

A randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

Velindre NHS Trust (UK)0 sites420 target enrollmentMay 18, 2006
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ConditionsOesophageal cancerCancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Oesophageal cancer
Sponsor
Velindre NHS Trust (UK)
Enrollment
420
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

  1. 2011 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22035459 2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23623280 3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28196063
Registry
who.int
Start Date
May 18, 2006
End Date
February 1, 2016
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Velindre NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •Amended 11/02/2009:
  • •The following points of the below criteria have been amended as follows:
  • •2\. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell, or undifferentiated) or Siewert type 1 tumour of the gastro\-oesophageal junction (GOJ) or Siewert Type 2 with no more than 2 cm mucosal extension into the stomach
  • •3\. Tumours staged with endoscopic ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1\-4N0\-1 confirming localised, non\-metastatic disease
  • •7\. Adequate cardio\-respiratory function for definitive CRT. (Echo or multiple\-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1\) greater than 1 litre)
  • •8\. Adequate renal function for definitive CRT (renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min
  • •9\. Written informed consent to participate in the trial
  • •Initial information at time of registration:
  • •1\. Patients older than 18 years of age who have been selected to receive potentially curative definitive chemo\-radiation
  • •2\. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma or squamous cell) or Siewert type 1 tumour of the gastro\-oesophageal junction (GOJ)

Exclusion Criteria

  • •Amended 11/02/2009:
  • •The following points of the below criteria have been amended as follows:
  • •3\. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation or may compromise survival
  • •Initial information at time of registration:
  • •1\. Patients who have had previous treatment for oesophageal carcinoma
  • •2\. Patients with metastatic disease i.e. M1a/coeliac nodes or M1b
  • •3\. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation
  • •4\. Patients with significant (greater than 2 cm) extension of tumour into the stomach

Outcomes

Primary Outcomes

Not specified

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