Feasibility trial of chemoradiation or surgery for oesophageal cancer

ISRCTN	ISRCTN89052791
DOI	https://doi.org/10.1186/ISRCTN89052791
Clinical Trials Information System (CTIS)	2009-013877-16
Protocol serial number	7864
Sponsor	United Bristol Healthcare NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

Submission date: 28/05/2010
Registration date: 28/05/2010
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-pilot-study-learn-more-about-2-treatment-plans-cancer-foodpipe

Contact information

Dr Joanna Nicklin
Scientific

MRC Health Services Research Collaboration
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Phone	+44
Email	joanna.nicklin@bristol.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomisation or registration interventional treatment trial
Secondary study design	Randomised controlled trial
Scientific title	Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study
Study objectives	The overall aim of this study is to determine whether a full multi-centre randomised trial of the two standard treatments for localised oesophageal squamous cell cancer is feasible.
Ethics approval(s)	North Somerset and South Bristol Research Ethics Committee, 30/10/2009, ref: 09/H0106/69
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophageal Cancer
Intervention	1. Induction chemotherapy followed by oesophagectomy 2. Induction chemotherapy followed by chemoradiotherapy Follow-up length: 24 months Study entry: randomisation or registration
Intervention type	Other
Primary outcome measure(s)	The proportion (and number) of eligible patients randomised in the feasibility study, measured at randomisation
Key secondary outcome measure(s)	1. Health related quality of life, measured at 16 and 24 weeks, 12, 18 and 24 months post-randomisation or registration 2. Survival, measured at one and two years post-randomisation or registration 3. Treatment related toxicity and morbidity, measured during treatment and 16 and 24 weeks, and 12, 18 and 24 weeks post-randomisation or registration
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Total final enrolment	5
Key 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.
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Health Services Research Collaboration

Bristol
BS8 2PR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/07/2014	13/11/2019	Yes	No
HRA research summary			28/06/2023	No	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link added.
13/11/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
14/03/2017: No publications found in PubMed, verifying study status with principal investigator