Randomised phase III study of docetaxel versus active symptom control in patients with relapsed gastric adenocarcinoma

ISRCTN	ISRCTN13366390
DOI	https://doi.org/10.1186/ISRCTN13366390
ClinicalTrials.gov (NCT)	NCT00978549
Clinical Trials Information System (CTIS)	2006-005046-37
Protocol serial number	C21276/A7737
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Cancer Research UK (UK) (ref: C21276/A7737)

Submission date: 19/09/2007
Registration date: 14/11/2007
Last edited: 19/03/2020

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-docetaxel-chemotherapy-for-advanced-cancer-of-the-stomach-the-oesophagus-or-the-junction-of-the-stomach-and-oesophagus

Contact information

Dr Hugo Ford
Scientific

Oncology Centre
Box 193
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Open-label two-arm multi-centre phase III randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised phase III study of docetaxel versus active symptom control in patients with relapsed gastric adenocarcinoma
Study acronym	COUGAR-02
Study objectives	To establish the role of chemotherapy with docetaxel as second line therapy for advanced gastric cancer in terms of overall survival. On 12/09/2008 the overall trial start and end dates were changed from 01/11/2007 and 30/04/2010 to 10/04/2008 and 10/10/2010, respectively. On 15/02/2011 the following changes were made to this trial record: 1. The overall trial end date was changed from 10/10/2010 to 28/02/2012. 2. The target participant number was changed from 320 to 180.
Ethics approval(s)	South West Research Ethics Committee, 28/12/2008, ref: 07/H0206/62
Health condition(s) or problem(s) studied	Advanced gastric cancer
Intervention	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.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	Docetaxel
Primary outcome measure(s)	Overall survival, measured as the time between the date of randomisation and the date of death from any cause.
Key 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
Completion date	10/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	180
Key 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
Key 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 breastfeeding 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
Date of first enrolment	10/04/2008
Date of final enrolment	10/10/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014	Yes	No
Basic results			No	No
Plain English results			No	Yes

Editorial Notes

19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)