Condition category
Cancer
Date applied
03/10/2017
Date assigned
12/10/2017
Last edited
06/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
At present, patients with cancer of the gullet (food pipe) are offered chemotherapy treatment before surgery, but there is no way of deciding in advance which patients are likely to gain the most benefit from chemotherapy and which patients are less likely to benefit from chemotherapy. The aim of this study is to assess the changes in DNA and proteins in the cancer that occur as a result of chemotherapy.

Who can participate?
Patients aged 18 and over with cancer of the gullet

What does the study involve?
All patients receive two cycles of chemotherapy given 3 weeks apart. Tissue is taken from the cancer before and 4-6 weeks after the last dose of chemotherapy to assess DNA repair gene activity. The patients’ clinical outcomes (disease-free and overall survival) are assessed at 6-12 months after chemotherapy.

What are the possible benefits and risks of participating?
This study will allow researchers to understand better which types of tumour respond best to this type of chemotherapy and how the tumour changed during treatment.

Where is the study run from?
Oxford University Hospital NHS Trust (UK)

When is the study starting and how long is it expected to run for?
January 2006 to November 2010

Who is funding the study?
1. Wellcome Trust (UK)
2. NIHR Biomedical Research Centre Oxford (UK)
3. Oxford University Clinical Academic Graduate School (UK)
4. NIHR University College Hospitals Biomedical Research Centre (UK)
5. Cancer Research UK Experimental Cancer Medicine Centre (UK)

Who is the main contact?
Dr Mark Middleton

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Middleton

ORCID ID

Contact details

Department of Oncology
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Additional identifiers

EudraCT number

2005-000834-34

ClinicalTrials.gov number

Protocol/serial number

Version 2.1 20.10.05

Study information

Scientific title

Phase II trial of neo-adjuvant Oxaliplatin and 5-fluorouracil in esophageal cancer

Acronym

Study hypothesis

DNA damage repair gene expression in tumours can predict clinical outcomes following chemotherapy and surgery.

Ethics approval

Oxfordshire Regional Ethics Committee, 05/03/2006

Study design

Non-randomized phase 2 clinical trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Esophageal cancer

Intervention

All patients received Oxaliplatin 130 mg/m2 IV on day 1, followed by 5FU 1gm/m2 per day on days 1-4. Two cycles given 3 weeks apart. Follow-up was for 6 months after the last cycle of chemotherapy.

Intervention type

Drug

Phase

Phase II

Drug names

Oxaliplatin, 5-fluorouracil

Primary outcome measures

1. DNA repair gene expression in tumour tissue, measured using microarray at baseline and 4-6 weeks after the last dose of chemotherapy.
2. Clinical outcomes, measured using disease-free survival and overall survival at 6-12 months post chemotherapy

Secondary outcome measures

Haplotype and DNA repair gene pathways measured using immunohistochemistry at baseline and 4-6 weeks after the last dose of chemotherapy

Overall trial start date

20/01/2006

Overall trial end date

30/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven operable oesophageal adenocarcinoma/squamous cell carcinoma
2. Age greater than or equal to 18 years
3. Suitable for neo-adjuvant chemotherapy according to local protocols
4. Subjects must be free of any clinically significant disease other than oesophageal cancer that would interfere with the study evaluations
5. Adequate haematologic, renal and hepatic function as demonstrated by laboratory values performed within 14 days prior to the administration of chemotherapy:
5.1. Absolute neutrophil count (ANC) ≥ 1500/mm3
5.2. Platelet count ≥ 100,000/ mm3
5.3. Haemoglobin ≥ 10g/dL
5.4. Urea and serum creatinine < 1.5 times upper limit of laboratory normal (ULN)
5.5. Creatinine clearance: more than 50ml (by Cockcroft Gault calc)
5.6. Total bilirubin < 1.5 times ULN
5.7. AST ≤ 3 times ULN
5.8. Alkaline phosphatase < 2 times ULN
6. Patients must have given written informed consent
7. Women of child-bearing potential must use an acceptable method of birth control during the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant exclusion criteria

1. Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to starting the study drug(s))
2. Known dihydropyrimidine dehydrogenase deficiency
3. Subjects known to be HIV, Hep B or Hep C positive

Recruitment start date

01/05/2006

Recruitment end date

01/02/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospital NHS Trust
OX3 7LE
United Kingdom

Sponsor information

Organisation

Churchill Hospital

Sponsor details

Department of Oncology
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

NIHR Biomedical Research Centre Oxford

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Oxford University Clinical Academic Graduate School

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR University College Hospitals Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK Experimental Cancer Medicine Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Full paper to be published in a scientific journal within the next 6 months.

IPD sharing statement
The datasets generated during and/or analysed during the current study have been archived and are no longer available.

Intention to publish date

01/01/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes