Feasibility trial of chemoradiation or surgery for oesophageal cancer

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophageal Cancer; Cancer; Oesophageal squamous cell cancer

• Registration Number: ISRCTN89052791
• Lead Sponsor: nited Bristol Healthcare NHS Foundation Trust (UK)

Brief Summary

2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24921919 results (added 13/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-28
• Study Completion: 2011-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Aged 18 years of age or older (either sex) 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 10 cm length
5. Considered sufficiently fit for both treatments in the trial by a surgeon and an oncologist, both of whom are members of the core multi-disciplinary team*
6. Willing to use contraception, if female and of child bearing age
7. Able to give informed written consent to participate in the randomised trial

*If the participant is of uncertain fitness for both treatments, then respiratory and cardiac function tests should be performed according to local practice within 4 weeks of randomisation. Suggested levels: forced expiratory volume in one second (FEV1) greater than 1.5 litres; cardiac ejection fraction greater than 50% of normal echocardiography.

Exclusion Criteria

1. Concomitant 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 2 cm gastric wall involvement (measured on EUS)
4. Previous treatment that compromises the ability to deliver definitive mediastinal chemoradiotherapy or to undergo oesophagectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified