321GO: Three, two or one-drug chemotherapy for advanced gastroesophageal cancer: a feasibility study in frail and/or elderly patients

ISRCTN	ISRCTN33934807
DOI	https://doi.org/10.1186/ISRCTN33934807
Secondary identifying numbers	MO08/8527

Submission date: 16/03/2008
Registration date: 15/07/2008
Last edited: 31/03/2022

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 of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-setting-up-a-trial-of-chemotherapy-for-frail-and-elderly-patients-with-advanced-cancer-of-the-food-pipe-and-stomach

Contact information

Prof Matt Seymour
Scientific

St James' Institute of Oncology
Bexley Wing
Level 4
St James' University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 343 8396
Email	Matt.Seymour@leedsth.nhs.uk

Study information

Study design	Multi-centre randomised controlled 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 below to request a patient information sheet
Scientific title	321GO: Three, two or one-drug chemotherapy for advanced gastroesophageal cancer: a feasibility study in frail and/or elderly patients
Study acronym	321GO
Study objectives	Is it feasible to perform a large randomised controlled trial comparing single-agent, two-drug or three-drug chemotherapy in frail elderly patients with advanced gastroesophageal cancer, for whom standard combination chemotherapy is considered unsuitable. On 22/02/2011 the overall trial end date was changed from 01/01/2010 to 18/02/2011.
Ethics approval(s)	Leeds (East) Research Ethics Committee on 01/07/2008
Health condition(s) or problem(s) studied	Incurable gastric or oesophageal carcinoma in frail or elderly patients
Intervention	Starting doses: Arm 1: EOX (control) - Epirubicin (40 mg/m2), oxaliplatin (104 mg/m2), X capecitabine (500mg/m2 twice a day [bd] for 21 days) Arm 2: OX - Oxaliplatin (104 mg/m2), X capecitabine (500 mg/m2 bd for 21 days) Arm 3: X capecitabine (1,000 mg/m2 bd for 14 days) These doses are 80% of the standard regimens. After 6 weeks (2 cycles), patients will be assessed and considered for escalation to full standard doses, provided no Common Toxicity Criteria (CTC) grade >=2 toxicity has occurred and the patient and clinician agree.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Epirubicin, oxaliplatin, capecitabine
Primary outcome measure	1. The rate of patient randomisation into 321GO over the 18 month recruitment period in the 2 participating cancer networks 2. The number of patients at each participating network considered for palliative chemotherapy for advanced GO cancer, and the proportion randomised into 321GO
Secondary outcome measures	1. The tolerability of each regimen, assessed in terms of the following: 1.1. The incidence of CTCAEv3 grade >= 3 non-haematological toxicities at 6 weeks 1.2. The incidence of SAEs and dose delays/reductions 1.3. The ability/willingness to dose-escalate to 100% at week 6 2. Patient acceptability scores at 12 and 24 weeks 3. Quality of life, nutritional and symptom changes at 0, 12 and 24 weeks: 3.1. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) with Gastroesophageal module 3.2. 24-point Nottingham Instrumental Activities of Daily Living (IADL) tool 3.3. Mini-nutritional assessment questionnaire 3.4. Mini-Mental State Examination 3.5. Charlson co-morbidity score 3.6. Euroqol (EQ-5D) questionnaire 4. Progression-free survival for the whole group (combining all 3 treatment arms)
Overall study start date	01/09/2008
Completion date	18/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Total final enrolment	55
Key inclusion criteria	1. Both males and females 2. Histologically confirmed carcinoma of the oesophagus, GO-junction or stomach, of either squamous, adenocarcinoma or undifferentiated type 3. With or without distant metastases, but if M0, must be planned for treatment with palliative intent 4. No previous chemotherapy for GO cancer 5. Considered by treating consultant to be fit/suitable for reduced-dose chemotherapy (normally WHO PS <=2) 6. Renal function: Glomerular filtration rate (GFR) (measured or estimated) >=30 ml/min 7. Hepatic function: Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) <=2.5 x upper limit of normal (ULN) and bili <= 1.5 x ULN 8. Projected life expectancy of at least 3 months 9. Unidimentionally measurable disease on computerised tomography (CT) or magnetic resonance imaging (MRI) scan with the response evaluation criteria in solid tumours (RECIST)
Key exclusion criteria	1. Fit, suitable and willing for standard full-dose combination chemotherapy with EOX (epirubicin, oxaliplatin, X capecitabine) or equivalent 2. Medical or psychiatric condition impairing ability to consent or comply with assessments including Quality of life questionnaire 3. Requiring ongoing treatment with a contraindicated medication 4. Age <18 years
Date of first enrolment	01/09/2008
Date of final enrolment	18/02/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St James' Institute of Oncology

Leeds
LS9 7TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

The Clinical Trials Research Unit
17 Springfield Mount
Leeds
LS2 9NG
England
United Kingdom

Website	http://www.leeds.ac.uk/medicine/nyctru/ctru_contents.htm
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Industry

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Roche UK (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/02/2017		Yes	No
Plain English results			31/03/2022	No	Yes

Editorial Notes

31/03/2022: Plain English results and total final enrolment added.
04/07/2017: Publication reference added