Condition category
Cancer
Date applied
19/09/2007
Date assigned
14/11/2007
Last edited
09/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Hugo Ford

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00978549

Protocol/serial number

C21276/A7737

Study information

Scientific title

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

Acronym

COUGAR-02

Study hypothesis

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

South West Research Ethics Committee, 28/12/2008, ref: 07/H0206/62

Study design

Open-label two-arm multi-centre phase III randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Docetaxel

Primary outcome measures

Overall survival, measured as the time between the date of randomisation and the date of death from any cause.

Secondary outcome measures

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

Overall trial start date

10/04/2008

Overall trial end date

10/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant 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

Recruitment start date

10/04/2008

Recruitment end date

10/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 245151
webmaster@addenbrookes.nhs.uk

Sponsor type

Government

Website

http://www.addenbrookes.org.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) (ref: C21276/A7737)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24332238

Publication citations

Additional files

Editorial Notes