Correlating the Tumoral Metabolic Progression Index to Patient's Outcome in Advanced Colorectal Cancer (CORIOLAN)

Inclusion Criteria:

• Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
• All standard chemotherapy agents (fluoropyrimidines, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab) are allowed as administered therapy before study entry.
• Age equal or over 18 years.
• Life expectancy of greater than 12 weeks.
• ECOG performance status ≤ 1.
• Participants must have normal organ and marrow function as defined below:

Total bilirubin within 2 × normal institutional upper limits AST/ALT/Alk Phosphatase levels < 5 × normal institutional upper limits Creatinine within 2 × normal institutional upper limits or creatinine clearance > 35mL/min

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Signed written informed consent (approved by an Independent Ethics Committee (IEC) and obtained prior to any study specific screening procedures).

Exclusion Criteria:

Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients receiving any experimental agents.
• Patients with uncontrolled brain metastases.
• Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
• Major surgery within four weeks.
• Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or any significant disease which, in the investigator's opinion, would exclude the patient from the study.
• Pregnancy (absence to be confirmed by urinary test on the days of the FDG PET-CT scan examinations) or breastfeeding.
• Uncontrolled Diabetes.
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
• Contra-indications to the use of MRI: cardiac stimulator, implanted cardiac wires, any implanted electronic devices, intra-ocular metallic foreign bodies.
• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent.