A randomised phase II/III multi-centre clinical trial of definitive chemo-radiaiton, with or without cetuximab, in carcinoma of the oesophagus - SCOPE 1

Velindre NHS Trust0 sites0 target enrollmentFebruary 26, 2007

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2007

End Date

October 10, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Velindre NHS Trust

•1\.Older than 18 years of age.
•2\.Have been selected to receive potentially curative definitive chemo\-radiation by a specialist Upper GI MDT including a designated upper GI surgeon.
•3\.Who are not suitable for surgery either for medical reasons or through patient choice.
•4\.Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell or undifferentiated carcinoma) 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.
•5\.Tumours staged with both endoscopic ultrasound (EUS) and spiral CT scan to be T1\-4, N0\-1 confirming localised, non\-metastatic disease (both within 6 weeks prior to randomisation, but the most recent within 4 weeks).
•6\.Total disease length (primary and lymph nodes) less than 10cm defined by EUS.
•7\.Patients clear of previous malignancies for a period of 5 years prior to randomisation.
•8\.WHO performance status 0\-1\.
•9\.Adequate cardiovascular function for safe delivery of chemo\-radiation in the opinion of the principal investigator.
•Where there is clinical concern patients should have an adequate cardiac ejection fraction \= 40% as determined by MUGA scan or ECHO (within 4 weeks prior to randomisation).

•1\.Patients who have had previous treatment for invasive oesophageal carcinoma or gastro\-oesophageal junction carcinoma (not including PDT or laser therapy for high grade dysplasia/carcinoma in\-situ).
•2\.Patients with metastatic disease i.e. M1a or M1b according to UICC TNM version 6\.
•3\.Patients with previous treatment for malignancy which compromises the ability to deliver definitive mediastinal chemo\-radiation or may compromise survival.
•4\. patients who have had a previous malignancy during the previous 5 years
•5\.Patients with significant (\>2cm) extension of tumour into the stomach.
•6\.Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
•7\.Patients who have had major surgery or major trauma in the 4 weeks prior to randomisation.
•8\.Patients who have been treated with a monoclonal antibody in the 4 weeks prior to randomisation.
•9\.Patients who have been treated with radiotherapy in the 3 months prior to randomisation.
•10\.Patients who need continued treatment with a contraindicated concomitant medication or therapy.