Clinical trial to identify biomarkers to select patients with esophageal cancer for oxaliplatin and 5-fluorouracil chemotherapy prior to surgery
| ISRCTN | ISRCTN18146225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18146225 |
| EudraCT/CTIS number | 2005-000834-34 |
| Secondary identifying numbers | Version 2.1 20.10.05 |
- Submission date
- 03/10/2017
- Registration date
- 12/10/2017
- Last edited
- 07/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Department of Oncology
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Non-randomized phase 2 clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Phase II trial of neo-adjuvant Oxaliplatin and 5-fluorouracil in esophageal cancer |
| Study objectives | DNA damage repair gene expression in tumours can predict clinical outcomes following chemotherapy and surgery. |
| Ethics approval(s) | Oxfordshire Regional Ethics Committee, 05/03/2006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Oxaliplatin, 5-fluorouracil |
| Primary outcome measure | 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 study start date | 20/01/2006 |
| Completion date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 38 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
Department of Oncology
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom
"ROR" |
https://ror.org/009vheq40 |
|---|
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Location
- United Kingdom
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full paper to be published in a scientific journal within the next 6 months. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study have been archived and are no longer available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/04/2016 | Yes | No | |
| Results article | results | 08/05/2018 | Yes | No |
Editorial Notes
07/08/2018: Publication reference added.
10/07/2018: Publication reference added.
