Follow-up to the MOSAIC study (multicentre international study of oxaliplatin/5-fluorouracil/leucovorin in the adjuvant treatment of colon cancer)

ISRCTN	ISRCTN38080578
DOI	https://doi.org/10.1186/ISRCTN38080578
Secondary identifying numbers	9015

Submission date: 28/09/2010
Registration date: 24/02/2011
Last edited: 18/03/2019

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

Not provided at time of registration

Study website

Contact information

Ms Laura Purandare
Scientific

Oncology Research Unit
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Phone	+44 12 0238 5624
Email	Laura.purandare@rbch.nhs.uk

Study information

Study design	Observational multicentre non-randomised validation of outcome measures follow-up study
Primary study design	Observational
Secondary study design	Non 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	A non-interventional follow-up to the MOSAIC study (multicentre international study of oxaliplatin/5-fluorouracil/leucovorin in the adjuvant treatment of colon cancer) up to 10 years and translational research
Study objectives	This study will involve analysis of tumours obtained from participants who previously participated in the MOSAIC (NEJM 2004 Jun 3;350(23):2343-51) trial. Prior to MOSAIC, several studies had established that post-operative 5-fluorouracil (5FU) chemotherapy could increase cure rates in colon cancer patients with surgically resectable tumours. Patients who received the combination of 5FU and oxaliplatin in the MOSAIC trial had superior outcomes, indicating the need for markers which predict which patients may benefit from the addition of oxaliplatin to post-operative therapy. Recruitment to the MOSAIC trial provides a sufficiently large sample of colon cancer patients to enable markers to be evaluated for their association with patient outcome and likelihood of benefit from therapy.
Ethics approval(s)	Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, 07/05/2009, ref: 09/H0501/30
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon, Rectum
Intervention	This is a non-interventional study, with a translational element.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Oxaliplatin, 5-fluorouracil, leucovorin
Primary outcome measure	1. Overall survival defined as the time from first dose of adjuvant therapy until death 2. Disease-free survival defined as local or distant recurrence of colon cancer, second primary colorectal cancer or death of any cause Primary analysis is scheduled for Q3 2011.
Secondary outcome measures	1. Time to recurrence-free defined as time to any event related to the same cancer. All same cancer recurrences and deaths from the same cancer are events. Second primary same cancers and other primary cancers are ignored. Death from other cancers, non-cancer-related death, treatment-related death, and lost to follow-up are censored observation. 2. Second cancers 3. Neuropathy (NCI/CTC) 4. Treatment of relapse, i.e. chemotherapy, surgery 5. Molecular markers will be associated with clinical data from the parent MOSAIC clinical study to determine the relationship between presence, absence or relative level of each molecular marker and clinical outcome
Overall study start date	16/03/2011
Completion date	16/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 1000; UK sample size: 264
Key inclusion criteria	1. Patients who were enrolled in the MOSAIC study and for whom a representative FPE tumour tissue specimen from their primary tumour is available 2. Male and female, lower age limit of 18 years
Key exclusion criteria	Participants who did not take part in the MOSAIC study
Date of first enrolment	16/03/2011
Date of final enrolment	16/03/2012

Locations

Countries of recruitment

Australia
Austria
Belgium
Denmark
England
Finland
France
Germany
Greece
Hungary
Israel
Italy
Netherlands
Norway
Poland
Portugal
Singapore
Spain
Sweden
Switzerland
United Kingdom

Study participating centre

Oncology Research Unit

Bournemouth
BH7 7DW
United Kingdom

Sponsor information

GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) (France)
Research organisation

22 Rue Malher
Paris
75004
France

Phone	+33 1 40 29 85 00
Email	Gercor@canceronet.com
Website	http://www.canceronet.com/
"ROR"	https://ror.org/024w4dn76

Funders

Funder type

Research organisation

Multidisciplinary Oncology Group Collaboration (Groupe Coopérateur Multidisciplinaire en Oncologie [GERCOR]) (France)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	conference abstract	20/05/2013		No	No

Editorial Notes

18/03/2019: Publication reference added.
12/03/2019: Internal review.
23/05/2017: No publications found in PubMed, verifying study status with principal investigator