A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemo-radiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET) - SCOPE 2

Velindre NHS Trust0 sites0 target enrollmentApril 10, 2017

Overview

No summary available.

Registry

who.int

Start Date

April 10, 2017

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Velindre NHS Trust

•1\.17 years of age or older.
•2\.Have been selected to receive potentially curative definitive chemoradiotherapy by a specialist Upper GI MDT.
•3\.Histologically confirmed adenocarcinoma, undifferentiated cancer or squamous cell carcinoma.
•4\.Tumours of the cervical, thoracic oesophagus, or gastro\-oesophageal junction (GOJ) with proximal extent of disease no more proximal than 15cm aboral and distal extent of primary tumour no more than 2 cm beyond the GOJ.
•5\. Tumours staged with spiral CT scan, PET\-CT with/without endoscopic ultrasound (EUS), to be T1\-4, N\-/\+ (provided total tumour length including nodes is \=10\). To be eligible for PET randomisation, the PET\-CT must be within 4 weeks of start date of treatment.
•6\. Total contiguous disease length \=10cm defined by CT, EUS and/or PET. This includes \=8cm primary tumour plus nodes within 2cm.
•7\. WHO performance status 0 or 1\.
•8\. Adequate haematological, renal, respiratory, cardiac and hepatic function, and are fit to receive all protocol treatment.
•9\. Patients with reproductive potential (male or female), who are sexually active during the duration of the trial, should be prepared to use a highly effective method of contraception preferably with low user dependency for at least six months after the last dose of chemoradiotherapy.
•10\. Patients who have provided written informed consent prior to randomisation.

•1\. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro\-oesophageal junction carcinoma
•2\. Patients with metastatic disease
•3\. Patients with other active malignancy or past malignancy in remission for less than 3 years except patients that have been curatively treated from the following conditions; basal cell carcinoma, Carcinoma\-in\-situ breast and carcinoma\-in\-situ cervix
•4\. Patients with \>2cm mucosal extension of tumour into the stomach or where the superior extent is proximal to 15 cm ab oral.
•5\. Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
•6\. Patients who need continued treatment with a contraindicated concomitant medication or therapy.
•7\. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
•8\. Patients with hearing impairment or sensory\-motor neuropathy of WHO grade \=2\.
•9\. Known hypersensitivity to IMPs.
•10\. Women who are pregnant or breastfeeding..