The change in PET and MRI measurements over time as a predictor for metastatic colorectal cancer outcome.

Phase 1

• Conditions: MedDRA version: 18.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Advanced colorectal cancer, refractory to all available medications; MedDRA version: 18.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006280-21-BE
• Lead Sponsor: Jules Bordet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-03
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 53

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.
•Participants should be candidate for a Phase I study
•The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type K-ras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
•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 during the assessment. For women of child-bearing 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 within one month.
•Signed written informed consent obtained prior to any study specific screening procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
•Participants who have had chemotherapy or targeted therapy 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.
•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 breast-feeding 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.
•Medical, geographical, sociological, psychological or legal conditions that would not allow the patient to complete the study or sign informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified