Contact information
Type
Scientific
Contact name
Mrs Sharon Ruddock
ORCID ID
Contact details
Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
-
s.p.ruddock@leeds.ac.uk
Additional identifiers
EudraCT/CTIS number
2013-000009-21
IRAS number
ClinicalTrials.gov number
Protocol/serial number
15037
Study information
Scientific title
GO2 - Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer: a randomised controlled trial
Acronym
GO2
Study hypothesis
The GO2 study is a randomised controlled trial (RCT) of palliative chemotherapy using oxaliplatin and capecitabine (OxCap) in frail/elderly patients with advanced GO cancer who are not fit to receive standard full-dose chemotherapy, but who are suitable for lower-dose chemotherapy. The trial will compare 3 dose levels of OxCap chemotherapy and a best supportive care (BSC) arm.
The aims of doing this study are:
1. To find out which dose of OxCap achieves the best balance of cancer control,toxicity, patient acceptability and quality of life for frailer patients with advanced cancer of the gullet or stomach.
2. To find out if there are any patient characteristics that could predict better orworse outcomes with chemotherapy at different doses.
3. To find out whether there is any benefit to giving chemotherapy to patients for whom there is substantial uncertainty about the role of chemotherapy.
Eligible and consenting participants will undergo a Comprehensive Health Assessment (CHA). Patients considered likely to benefit from chemotherapy will be randomised to receive one of three dose intensities of OxCap. Patients considered as uncertain to benefit from chemotherapy will be randomised to one of the three dose intensities of OxCap or a BSC arm.
GO2 aims to recruit a minimum of 500 patients across the UK over a 3 year period. It will provide the first RCT evidence to guide the use of palliative chemotherapy in elderly/frail patients with advanced GO cancer, and has the potential to have significant impact upon clinical practice.
Ethics approval(s)
Ethics board: Yorkshire and the Humber Leeds East, 02/09/2013, ref: 13/YH/0229
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus
Intervention
GO2 has no fixed sample size. The trial aims to recruit a minimum of 500 participants to the chemotherapy arms, and an additional 30 participants to the BSC arm over 3 years. However, should accrual rates exceed expectations and 750 participants be recruited prior to 3 years. trial closure would then be considered.
Best supportive care (BSC): Participants randomised to receive best supportive care (BSC) will be treated according to local policy.
OxCap 100%: Oxaliplatin 130mg/m^2 day 1 Capecitabine 625mg/m^2 bd x 21 days
OxCap 80%: Oxaliplatin 104mg/m^2 day 1 Capecitabine 500mg^m2 bd x 21 days
OxCap 60%: Oxaliplatin 78mg/m^2 day 1 Capecitabine 375mg/m^2 bd x 21 days
Follow Up Length: 12 months
Study Entry : Single Randomisation only
Intervention type
Other
Primary outcome measure
Chemotherapy intensity comparison:
1. Progression free survival
Chemotherapy vs best supportive care comparison
1. Overall survival
Secondary outcome measures
Chemotherapy intensity comparison:
1. Participant reported fatigue
2. Time to deterioration of participant reported fatigue
3. Overall treatment utility
4. Quality of life and symptoms
5. Toxicity
6. Overall survival
7. Quality adjusted survival
8. Best response
Chemotherapy vs best supportive care comparison:
1. Participant reported fatigue
2. Quality of life
Comprehensive Health Assessment (CHA) pre-randomisation
EQ-VAS weekly until week 18
Short follow-up questionnaire 3-weekly until week 18, then weeks 27, 36 and 52
Limited Health Assessment week 9
Overall study start date
01/09/2013
Overall study end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically or cytologically confirmed carcinoma of the oesophagus, GO junction or stomach
2. With or without distant metastases, but if M0, being treated with palliative intent
3. Considered by the treating physician to be fit/suitable for any of the GO2 regimens.
4. Renal function: estimated or measured GFR >=30 ml/min (if in the range 3050ml/min, reduced doses of both drugs must be used)
5. Hepatic function: bilirubin <3 times upper limit of normal (xULN) (if in the range 1.53xULN, reduced doses of both drugs must be used)
6. Bone marrow function: absolute neutrophil count >=1.5 x10^9/l; white blood cell count >=3 x10^9/l; platelets >=100 x10^9/l.
7. Written informed consent
8. Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned Sample Size: 780; UK Sample Size: 780
Total final enrolment
558
Participant exclusion criteria
1. Fit, suitable (as judged by the treating clinician) and willing for standard full dose combination chemotherapy with EOX or equivalent
2. Previous palliative chemotherapy for GO cancer
3. Medical or psychiatric condition impairing ability to consent or comply with oral chemotherapy or trial assessments (including patient reported outcome measures)
4. Other malignancy if, in the opinion of the treating physician, this would significantly impede interpretation of the outcome of the trial treatment
5. Age <18 years
Recruitment start date
08/01/2014
Recruitment end date
31/10/2017
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
Study participating centre
58 other sites
-
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Faculty Research Office
University of Leeds
Room 10.110
Level 10 Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
31/12/2019
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | quality of life results presented at ESMO | 01/10/2019 | 04/02/2020 | No | No |
| Abstract results | results presented at ASCO | 20/05/2019 | 04/02/2020 | No | No |
| Plain English results | 16/10/2020 | No | Yes | ||
| Results article | 01/06/2021 | 17/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |