Condition category
Cancer
Date applied
28/09/2010
Date assigned
24/02/2011
Last edited
08/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.canceronet.com/gercor_ang/presentation/index.asp

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 (0)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

Colorectal cancer is one of the most common cancers. Despite improvements in treatment, approximately 40 - 50% of patients with surgically resected colon tumours ultimately die from recurrence of cancer. Improved success in the treatment of colon cancer requires a better understanding of each patient's risk of recurrence and likelihood of benefit with post-operative therapy.

The outcome of patients with the same stage of colon cancer is varied. Studies have shown that the molecular characteristics of colon tumours vary considerably across patients, indicating that molecular markers may predict the clinical behaviour and responsiveness to therapy for individual patients. If tumour molecular markers can be identified which correlate with outcome following treatment, treatments can be optimally tailored for each patient. The aim of this study is to identify and potentially validate molecular markers (any kind of molecule indicating the existence of a chemical or physical process) which correlate with colon tumour behaviour.

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.

Co-sponsor details:
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust (UK)
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
Dorset BH7 7DW, UK
Website: http://www.rbch.nhs.uk/

Intervention type

Drug

Phase

Not Applicable

Drug names

Oxaliplatin, 5-fluorouracil, leucovorin

Primary outcome measures

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

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
Gercor@canceronet.com

Sponsor type

Research organisation

Website

http://www.canceronet.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes