ISRCTN89052791
Completed
未知
Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study
nited Bristol Healthcare NHS Foundation Trust (UK)0 sites5 target enrollmentMay 28, 2010
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- nited Bristol Healthcare NHS Foundation Trust (UK)
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24921919 results (added 13/11/2019)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
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