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

• Conditions: oesophageal cancer; MedDRA version: 12Level: LLTClassification code 10030151Term: Oesophageal cancer

• Registration Number: EUCTR2009-013877-16-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-23
• Last Update Posted: 16 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified