Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
Last edited
22/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Lyddiard

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OE02

Study information

Scientific title

Acronym

Study hypothesis

To investigate in patients considered to have resectable cancer of the oesophagus whether pre-operative chemotherapy:
1. Prolongs survival
2. Affects physical well-being

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer

Intervention

1. One group receives pre-operative chemotherapy followed by surgery
2. The other group = Control group receives surgery alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Survival time

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1992

Overall trial end date

30/06/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Tumour considered resectable
2. No evidence of cervical lymph node involvement or metastases
3. Creatinine clearance ≥60 ml/min
4. Total white blood cell count ≥3.5 x 109l
5. Platelet count ≥100 x 109l
6. No indication for urgent resection
7. No previous chemotherapy, radiotherapy or surgery for current oesophageal cancer
8. No other previous or concomitant malignant disease

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

800

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/1992

Recruitment end date

30/06/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2009 long term results in http://www.ncbi.nlm.nih.gov/pubmed/19770374

Publication citations

  1. Long term results

    Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE, Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer., J. Clin. Oncol., 2009, 27, 30, 5062-5067, doi: 10.1200/JCO.2009.22.2083.

Additional files

Editorial Notes