Condition category
Cancer
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Joanna Nicklin

ORCID ID

Contact details

MRC Health Services Research Collaboration
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
joanna.nicklin@bristol.ac.uk

Additional identifiers

EudraCT number

2009-013877-16

ClinicalTrials.gov number

Protocol/serial number

7864

Study information

Scientific title

Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study

Acronym

Study hypothesis

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. This will be achieved by undertaking a randomised pilot trial of induction chemotherapy and oesophagectomy versus induction chemotherapy and definitive chemoradiotherapy with integrated qualitative research to establish recruitment rates, to understand barriers to recruitment and to pilot procedures and trial outcome measures.

In addition, research will be undertaken to establish methods to identify patients eligible for randomisation using records from multi-disciplinary team meetings. This will determine and maximise recruitment and allow estimation of potential numbers for a full trial. Methods will also be used to reach consensus between health professionals and participants regarding clinically important treatment effects. These treatment effects will then be tested in the full trial. The final part of the feasibility study is to develop an intervention (information checklist) for surgeons, oncologists and nurses to use during consultations to describe the two standard treatments. This will be informed by information obtained from systematic reviews, the consensus methods, qualitative analysis of audio-recordings of consultations and semi-structured interviews with participants, in which their understanding of information provided will be elicited.

Ethics approval

North Somerset and South Bristol Research Ethics Committee on 30/10/2009 (ref: 09/H0106/69)

Study design

Multicentre randomisation or registration interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The proportion (and number) of eligible patients randomised in the feasibility study, measured at randomisation

Secondary outcome measures

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

Overall trial start date

01/01/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 30; UK sample size: 30

Participant 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

Recruitment start date

01/01/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Health Services Research Collaboration
Bristol
BS8 2PR
United Kingdom

Sponsor information

Organisation

United Bristol Healthcare NHS Foundation Trust (UK)

Sponsor details

Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom

Sponsor type

Government

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes