Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy

ISRCTN ISRCTN29580179
DOI https://doi.org/10.1186/ISRCTN29580179
ClinicalTrials.gov (NCT) NCT01243398
Clinical Trials Information System (CTIS) 2007-005391-13
Protocol serial number OCTO_005
Sponsor University of Oxford (UK)
Funders Cancer Research UK (UK) - main funding, Astra Zeneca (UK) - Supplying trial medication (Gefitinib) and placebo
Submission date
25/09/2007
Registration date
14/11/2007
Last edited
26/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-gefitinib-for-people-with-advanced-cancer-of-the-foodpipe-cog-trial

Contact information

Ms Lynnda Peachey
Scientific

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

Study information

Primary study designInterventional
Study designNational multi-centre phase III randomised double-blind placebo-controlled trial
Secondary study designRandomised controlled trial
Scientific titlePhase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy
Study acronymCOG
Study objectivesThat 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(s)Added 26/10/09: Multicentre Research Ethics Committee (MREC) approved 20/10/2008
Health condition(s) or problem(s) studiedOesophageal cancer
Intervention450 (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 typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Gefitinib (Iressa®)
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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

Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration450
Key inclusion criteriaPrior 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
Key exclusion criteriaPrior 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.
Date of first enrolment01/03/2009
Date of final enrolment30/09/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

COG Trial Co-ordinator
Oxford
OX3 7DQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2014 Yes No
Plain English results No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)

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