Condition category
Cancer
Date applied
25/09/2007
Date assigned
14/11/2007
Last edited
30/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Lynnda Peachey

ORCID ID

Contact details

COG Trial Co-ordinator
Oncology Clinical Trials Office (OCTO)
Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
off Roosevelt Drive
Headington
Oxford
OX3 7DQ
United Kingdom
+44 (0)1865 617016
lynnda.peachey@clinpharm.ox.ac.uk

Additional identifiers

EudraCT number

2007-005391-13

ClinicalTrials.gov number

NCT01243398

Protocol/serial number

OCTO_005

Study information

Scientific title

Acronym

COG

Study hypothesis

That gefitinib (Iressa®) 500 mg once daily will halt/slow the progression of oesophageal adenocarcinoma and squamous cancers, and thereby improve the survival of patients with these cancers.

As of 15/02/2011 the anticipated end date for this trial has been updated from 01/09/2010 to 30/09/2011.

Ethics approval

Added 26/10/09: Multicentre Research Ethics Committee (MREC) approved 20/10/2008

Study design

National multi-centre phase III randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oesophageal cancer

Intervention

450 (225 per arm) patients will be randomised to either Gefitinib 500 mg (Iressa®) or placebo.
As of October 2009: recruiting

Duration of the interventions: The trial will close 6 months after the end of recruitment or when 389 events have occurred.

Intervention type

Drug

Phase

Not Specified

Drug names

Gefitinib (Iressa®)

Primary outcome measures

Overall survival, assessed at each visit (every 4 weeks) or in-between if death is reported to site by family/friends until the end of trial.

Secondary outcome measures

1. Toxicity of gefitinib monotherapy in oesophageal cancer patients, assessed through Adverse Events (AE) and Serious Adverse Events (SAE) reporting (assessed at each visit or in between when reported by patients/family)
2. Quality of life, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-OES18 at baseline, 4 weeks, 8 weeks and 12 weeks
3. Time to clinical or radiological progression, assessed by the following:
3.1. Examination by medical staff at each visit
3.2. CT Scans (chest and abdomen) at baseline, 4, 8 and 16 weeks and then every 8 weeks until the end of trial
3.3. Chest X-rays at baseline, 4, 8, 12 and 16 weeks and then every 8 weeks until the end of trial
4. Identification of genetic signature associated with benefit, via blood samples and tissue taken at biopsy using Deoxyribonucleic Acid (DNA) microarray technology to identify genes associated with response and prognosis. Please note that this will be done by HANDEL (a translational research project) which will run in parallel to the COG Trial as a separate protocol

Overall trial start date

01/03/2009

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Prior to 26/10/09:
1. Aged greater than 18 years
2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
3. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease
4. Creatinine clearance greater than 30 ml/min; alkaline phosphatase, bilirubin and Alanine aminotransferase (ALT) less than 2 x Upper Limit of Normal (ULN); haemoglobin greater than 10 g/dL
5. World Health Organization (WHO) performance Status 0, 1 or 2
6. Measurable or evaluable disease by Computerised Tomography (CT) scan
7. Able to swallow tablets
8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry
9. Patients must complete the Quality Of Life (QOL) baseline questionnaire

Amended 26/10/09:
1. Aged greater than 18 years
2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
3. Histologically proven adenocarcinoma, squamous cell cancer or poorly differentiated epithelial malignancy
4. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease [date of last administration of chemotherapy must be >6 weeks prior to randomisation]
5. World Health Organization (WHO) performance Status 0, 1 or 2
6. Measurable or evaluable disease by Computerised Tomography (CT) scan
7. Able to swallow tablets
8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450

Participant exclusion criteria

Prior to 26/11/09:
1. Previous malignancy not treated curatively
2. Previous malignancy treated curatively less than 5 years ago
3. Medical condition considered to interfere with the safe participation in the trial
4. Radiotherapy to site of measurable or evaluable disease in the last month
5. Pregnancy
6. Not able to give written informed consent

Amended 26/101/09:
1. Presence of previous or other malignancy likely to confound results or interfere with gefitinib therapy
2. Medical condition considered to interfere with the safe participation in the trial
3. Radiotherapy to site of measurable or evaluable disease in the last 4 weeks
4. Pregnancy
5. Sexually active patients of child-bearing potential not using adequate contraception* (male and female) [post menopausal women must have been amenorrheic for at least 12 months to be considered as having non-child-bearing potential]
6. Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
7. Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
8. Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
9. Known severe hypersensitivity to gefitinib or any of the excipients of this product
10. On other cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications

* For female trial participants: birth control pills, approved contraceptive implant, spermicidal foam and condoms, intrauterine device, or prior tubal ligation. For male trial participants: condoms and spermicidal foams or prior vasectomy.

Recruitment start date

01/03/2009

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

COG Trial Co-ordinator
Oxford
OX3 7DQ
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Oncology Clinical Trials Office (OCTO)
Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
off Roosevelt Drive
Headington
Oxford
OX3 7DQ
United Kingdom
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) - main funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Astra Zeneca (UK) - Supplying trial medication (Gefitinib) and placebo

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24950987

Publication citations

  1. Results

    Dutton SJ, Ferry DR, Blazeby JM, Abbas H, Dahle-Smith A, Mansoor W, Thompson J, Harrison M, Chatterjee A, Falk S, Garcia-Alonso A, Fyfe DW, Hubner RA, Gamble T, Peachey L, Davoudianfar M, Pearson SR, Julier P, Jankowski J, Kerr R, Petty RD, Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial., Lancet Oncol., 2014, 15, 8, 894-904, doi: 10.1016/S1470-2045(14)70024-5.

Additional files

Editorial Notes