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 |
| EudraCT/CTIS number | 2007-005391-13 |
| ClinicalTrials.gov number | NCT01243398 |
| Secondary identifying numbers | OCTO_005 |
- 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
Contact information
Ms Lynnda Peachey
Scientific
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
| Phone | +44 (0)1865 617016 |
|---|---|
| lynnda.peachey@clinpharm.ox.ac.uk |
Study information
| Study design | National multi-centre phase III randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy |
| Study acronym | COG |
| Study objectives | 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(s) | Added 26/10/09: Multicentre Research Ethics Committee (MREC) approved 20/10/2008 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gefitinib (Iressa®) |
| Primary outcome measure | 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 study start date | 01/03/2009 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 450 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
COG Trial Co-ordinator
Oxford
OX3 7DQ
United Kingdom
OX3 7DQ
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
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
England
United Kingdom
| heather.house@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Cancer Research UK (UK) - main funding
No information available
Astra Zeneca (UK) - Supplying trial medication (Gefitinib) and placebo
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/07/2014 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
