Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Ms Laura Purandare
ORCID ID
Contact details
Oncology Research Unit
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
+44 12 0238 5624
Laura.purandare@rbch.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9015
Study information
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
Acronym
Study hypothesis
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
Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee, 07/05/2009, ref: 09/H0501/30
Study design
Observational multicentre non-randomised validation of outcome measures follow-up study
Primary study design
Observational
Secondary study design
Non 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
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
Phase
Not Applicable
Drug names
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 trial start date
16/03/2011
Overall trial end date
16/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 1000; UK sample size: 264
Participant exclusion criteria
Participants who did not take part in the MOSAIC study
Recruitment start date
16/03/2011
Recruitment end date
16/03/2012
Locations
Countries of recruitment
Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, United Kingdom
Trial participating centre
Oncology Research Unit
Bournemouth
BH7 7DW
United Kingdom
Sponsor information
Organisation
GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) (France)
Sponsor details
22 Rue Malher
Paris
75004
France
+33 1 40 29 85 00
Gercor@canceronet.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Multidisciplinary Oncology Group Collaboration (Groupe Coopérateur Multidisciplinaire en Oncologie [GERCOR]) (France)
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
Basic results (scientific)
Publication list
2013 conference abstract in: http://ascopubs.org/doi/abs/10.1200/jco.2013.31.15_suppl.3524