Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer
| ISRCTN | ISRCTN44687907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44687907 |
| EudraCT/CTIS number | 2013-000009-21 |
| Secondary identifying numbers | 15037 |
- Submission date
- 10/09/2013
- Registration date
- 10/09/2013
- Last edited
- 25/10/2022
- 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
Contact information
Mrs Sharon Ruddock
Scientific
Scientific
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 |
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | GO2 - Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer: a randomised controlled trial |
| Study 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 |
| 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 |
Eligibility
| 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 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 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 centres
University of Leeds
Leeds
LS2 9JT
United Kingdom
LS2 9JT
United Kingdom
58 other sites
-
United Kingdom
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Faculty Research Office
University of Leeds
Room 10.110, Level 10 Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
| Website | http://www.leeds.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will 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 |
Editorial Notes
25/10/2022: Internal review.
17/05/2021: Publication reference added.
16/10/2020: Cancer Research UK lay results summary link added to Results (plain English).
04/02/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.
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.
