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| Randomised phase III study of docetaxel versus active symptom control in patients with relapsed gastric adenocarcinoma |
| Source of record | UK Trials |
| ISRCTN | ISRCTN13366390 |
| Date ISRCTN assigned | 14/11/2007 |
| Local reference number(s) | C21276/A7737 |
| Public title | Randomised phase III study of docetaxel versus active symptom control in patients with relapsed gastric adenocarcinoma |
| Scientific title | |
| Acronym | COUGAR-02 |
| Disease/condition/study domain | Advanced gastric cancer |
| Study hypothesis | To establish the role of chemotherapy with docetaxel as second line therapy for advanced gastric cancer in terms of overall survival. |
| Design/methodology | Open-label, two-arm, multi-centre, phase III, randomised controlled trial. |
| Research ethics review | Ethics approval pending as of 14/11/2007 from the South West Research Ethics Committee (REC ref: 07/H0206/62). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients with histologically confirmed adenocarcinoma of the stomach (including Siewert-Stein type II and III adenocarcinoma of the oesophago-gastric junction) 2. Age 18 years or older 3. Advanced disease not amenable to curative treatment 4. Documented progressive disease while receiving or within 6 months of completion of first line chemotherapy with a platinum and fluoropyrimidine based therapy either for advanced disease or as neoadjuvant/perioperative therapy 5. Estimated life expectancy greater than or equal to 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 7. Satisfactory haematologic (haemoglobin [Hb] greater than or equal to 10 g/dL, White Blood Cells [WBC] greater than or equal to 3.0 x 10^9/L, Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^9/L, Platelets (Plt) greater than or equal to 100 x10^9/L), renal (creatinine less than or equal to Upper Limit of Normal [ULN]) and hepatic (total Bilirubin less than or equal to ULN, Alanine aminotransferase (ALT) less than or equal to 1.5 x ULN, Alkaline Phosphatase (ALP) less than or equal to 5 x ULN) function 8. Ability to give informed consent 9. Completion of baseline questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and EORTC-QLQ-STO22 [gastric cancer-specific QLQ] and EuroQoL (EQ-5D) questionnaire) 10. Patients of both sexes with reproductive potential must be willing to employ barrier contraceptives whilst on treatment and for 3 months after completion of treatment |
| Participants - exclusion criteria | 1. Cerebral or leptomeningeal metastasis 2. Prior chemotherapy with taxanes 3. Peripheral neuropathy 4. More than one prior chemotherapy regimen in advanced setting 5. Previous malignancy except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia 6. Pregnant or breast-feeding female patient 7. Any medical or psychiatric condition which would influence the ability to provide informed consent 8. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial |
| Patient information material | |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 30/04/2010 |
| Status of trial | Ongoing |
| Target number of participants | 320 |
| Interventions | Arm A: chemotherapy with docetaxel plus active symptom control for 18 weeks. The participants in this arm will have treatment once every 3 weeks and will receive up to 6 cycles of docetaxel intravenously at a dose of 75 mg/m^2 (total of 18 weeks of treatment). Arm B: active symptom control for 18 weeks. Active symptom control may include administration of analgesics, anti-emetics, steroids, palliative radiotherapy and/or any other supportive measures deemed appropriate by the treating clinician. |
| Primary outcome measure(s) | Overall survival, measured as the time between the date of randomisation and the date of death from any cause. |
| Secondary outcome measure(s) | 1. Time to documented progression 2. Response rates to docetaxel. This will be assessed using the Response Criteria In Solid Tumours (RECIST) at baseline and after 3 and 6 cycles of treatment. The best overall response achieved over the treatment period will be determined 3. Toxicity of docetaxel. Docetaxel related toxicity data will be collected at the end of each of the chemotherapy cycles prior to the start of the next cycle. In addition, all Adverse Events (AEs) will be monitored and recorded from randomisation until 21 days after the last administration of docetaxel 4. Quality of life, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 vs3 and QLQ-STO22. Quality of life data will be collected at baseline and then after 3, 6, 9, 12, 18 and 24 weeks from start of treatment 5. Health economic evaluation. The EuroQoL (EQ-5D) health outcome instrument is to be used for this assessment. The EQ-5D will be completed at baseline and then at every outpatient visit until death |
| Sources of funding | Cancer Research UK (UK) (ref: C21276/A7737) |
| Sponsor name | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Sponsor details | Box 277 Addenbrooke's Hospital Hills Road Cambridge United Kingdom CB2 0QQ |
| Sponsor telephone | +44 (0)1223 245151 |
| Sponsor fax | +44 (0)1223 348494 |
| Sponsor email | webmaster@addenbrookes.nhs.uk |
| Sponsor website | http://www.addenbrookes.org.uk/ |
| Contact name | Dr Hugo Ford |
| Contact details | Oncology Centre Box 193 Addenbrooke's Hospital Hills Road Cambridge United Kingdom CB2 0QQ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN13366390 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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