Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Mrs Sharon Ruddock


Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
United Kingdom

Additional identifiers

EudraCT number

2013-000009-21 number

Protocol/serial number


Study information

Scientific title

GO2 - Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer: a randomised controlled trial



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

Ethics board: Yorkshire and the Humber – Leeds East, 02/09/2013, ref: 13/YH/0229

Study design

Randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus


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



Phase III

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants

Planned Sample Size: 780; UK Sample Size: 780

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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
United Kingdom

Trial participating centre

58 other sites
United Kingdom

Sponsor information


University of Leeds (UK)

Sponsor details

Faculty Research Office
University of Leeds
Room 10.110
Level 10 Worsley Building
Clarendon Way
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/08/2017: Added recruitment dates, publication and dissemination plan, IPD sharing statement. 04/08/2017: The overall trial end date was changed from 31/08/2016 to 31/12/2018.