Condition category
Cancer
Date applied
10/09/2013
Date assigned
10/09/2013
Last edited
14/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Sue Bell

ORCID ID

Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
s.e.bell@leeds.ac.uk

Additional identifiers

EudraCT number

2013-000009-21

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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15037

Ethics approval

Ethics board: Yorkshire and the Humber – Leeds East, Date of ethics approval 2 September 2013, ref: 13/YH/0229

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

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

Phase

Phase III

Drug names

Primary outcome measures

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

01/09/2013

Overall trial end date

31/08/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

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

01/09/2013

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Research Unit (CTRU)
Leeds
LS2 9JT
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
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

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

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

Publication citations

Additional files

Editorial Notes