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

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal Cancer, Cancer, Colon Cancer, Rectal Cancer, PET, PET-CT, MRI, Diffusion MRI, Apparent Diffusion Coefficient, ADC, Metabolic Progression Index Read More

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.
• The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type Kras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
• Participants should be candidate for a Phase I study
• 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 during the assessment. For women of childbearing potential a pregnancy test (urinary or serum) must be performed within 7 days prior to inclusion and it must be negative. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately within one month.
• Signed written informed consent 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 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
• Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study.
• Patients receiving any experimental agents during the assessment time period.
• Patients with uncontrolled brain metastases.
• Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
• Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study
• 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 or breastfeeding before the FDG PET-CT scan examinations
• 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.