Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study - Feasibility trial of chemoradiation or surgery for oesophageal cancer

niversity Hospitals Bristol NHS Foundation Trust0 sitesOctober 23, 2009

Overview

No summary available.

Registry

who.int

Start Date

October 23, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospitals Bristol NHS Foundation Trust

•Inclusion criteria
•This study will include participants:
•1\. Aged 18 years of age or older on the date of first clinic appointment.
•2\. With histologically confirmed oesophageal squamous cell cancer.
•3\. With tumours staged as T2N0/1M0, T3N0/1M0, T4N0/1M0, where the T4 tumour involves the diaphragmatic crura or mediastinal pleura only (TNM classification).
•4\. With a total primary tumour and nodes less than 10cm length.
•5\. Considered sufficiently fit for both treatments in the trial by a surgeon and an oncologist who are both core members of an upper gastro intestinal MDT\*.
•6\. Willing to use contraception, if female and of child bearing age.
•7\. Able to give informed written consent to participate.
•\*If the participant is of uncertain fitness for both treatments, then respiratory and cardiac function tests will be performed according to local practice within 4 weeks of randomisation. Suggested levels: FEV1 \>1\.5 litres; cardiac ejection fraction \>50% of normal echocardiography.

•Exclusion criteria
•Participants will be excluded from entry into the trial if they have:
•1\. Concommitant or past malignancies within five years prior to randomisation, except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
•2\. Prior treatment for oesophageal cancer (not including photodynamic therapy or laser therapy for high grade dysplasia or carcinoma in situ).
•3\. Type I or II tumours of the oesophago\-gastric junction with more than 2cm gastric wall involvement (measured on EUS).
•4\. Previous treatment that compromises the ability to deliver definitive mediastinal chemoradiptherapy or to undergo oesophagectomy.
•Any queries about whether a patient is eligible to enter the trial will be addressed by the study team prior to entry. Concerns will then be discussed with the Chief Investigator.