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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN38080578

Enrollment

1000

Registered

2011-02-24

Start date

2011-03-16

Completion date

Unknown

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

This is a non-interventional study, with a translational element.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Participants who did not take part in the MOSAIC study

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026