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| Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy |
| Source of record | UK Trials |
| ISRCTN | ISRCTN29580179 |
| Date ISRCTN assigned | 14/11/2007 |
| Local reference number(s) | OCTO_005 |
| Public title | Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy |
| Scientific title | |
| Acronym | COG |
| Disease/condition/study domain | Oesophageal cancer |
| 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. |
| Design/methodology | National, multi-centre, phase III, randomised, double-blind, placebo-controlled trial. |
| Research ethics review | To be submitted at the end of October 2007 to the Multicentre Research Ethics Committee (MREC) (as of 25/09/2007). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | 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 |
| Patient information material | |
| Anticipated start date | 01/02/2008 |
| Anticipated end date | 01/09/2010 |
| Status of trial | Ongoing |
| Target number of participants | 450 |
| Interventions | 450 (225 per arm) patients will be randomised to either Gefitinib 500 mg (Iressa®) or placebo. Duration of the interventions: The trial will close 6 months after the end of recruitment or when 389 events have occurred. |
| 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. |
| 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 |
| Trial website | http://www.octo-oxford.org.uk/alltrials/insetup/COG.html |
| Sources of funding | 1. Cancer Research UK (UK) - main funding 2. Astra Zeneca (UK) - Supplying trial medication (Gefitinib) and placebo |
| Sponsor name | 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 United Kingdom OX3 7DQ |
| Sponsor email | heather.house@admin.ox.ac.uk |
| Sponsor website | http://www.ox.ac.uk |
| Contact name | Prof David Ferry |
| Contact details | Royal Wolverhampton Hospitals NHS Trust Wolverhampton Road Heath Town Wolverhampton West Midlands United Kingdom WV10 0QP |
| Contact email | member@ferryd.freeserve.co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN29580179 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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