Condition category
Cancer
Date applied
16/03/2008
Date assigned
15/07/2008
Last edited
04/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Matt Seymour

ORCID ID

Contact details

St James' Institute of Oncology
Bexley Wing
Level 4
St James' University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 343 8396
Matt.Seymour@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MO08/8527

Study information

Scientific title

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

Acronym

321GO

Study hypothesis

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

Leeds (East) Research Ethics Committee on 01/07/2008

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Phase II

Drug names

Epirubicin, oxaliplatin, capecitabine

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

18/02/2011

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

18/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James' Institute of Oncology
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.leeds.ac.uk/medicine/nyctru/ctru_contents.htm

Funders

Funder type

Industry

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

Funder name

Roche UK (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28095397

Publication citations

Additional files

Editorial Notes

04/07/2017: Publication reference added