Advanced colorectal cancer, refractory to all available medications MedDRA version: 18.1 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]Fluoro-2-Deoxy-D-Glucose
Pharmaceutical Form: Solution for injection
INN or Proposed INN: fludeoxyglucose (18F)
Other descriptive name: FDG
Concentration unit: MBq/ml megabecquerel
Sponsors
Jules Bordet Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the spontaneous evolution of tumoral metabolic progression index measured by serial FDG PET-CT without any intercurrent antitumor therapy as a prognostic factor for overall survival in patients with advanced colorectal cancer.;Secondary Objective: •Test TMPI as a prognostic marker for PFS. •Assess the prognostic value of baseline tumor FDG uptake on PFS and OS. •Compare TMPI to classical clinico-biologic assessment of prognosis (alkaline phosphatase, platelets count, LDH, tumor bulk) •Test the prognostic value of MRI based apparent diffusion coefficient (ADC) and variation of vADC based on voxel-based diffusion maps. •Translational research: -To identify and quantify tumor-specific rearrangements in plasma DNA using next-generation sequencing. -To characterize which of these tumor-specific rearrangements in plasma DNA form genomic and epigenetic determinants of tumoral metabolic progression guided by FDG-PET-CT metabolic imaging. -To identify these tumor-specific rearrangements in previous tumor tissue. -To analyze whether CTC levels correlate with tumoral metabolic progression guided by FDG PET-CT metabolic imaging. -To assess the prognostic value of CTCs on overall survival. ;Primary end point(s): To assess the spontaneous evolution of tumoral metabolic progression index measured by serial FDG PET-CT without any intercurrent antitumor therapy as a prognostic factor for overall survival in patients with advanced colorectal cancer.;Timepoint(s) of evaluation of this end point: At baseline and after two weeks to be correlated with the patient overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To test tumoral metabolic progression index as a prognostic marker for progression free survival. 2. To assess the prognostic value of baseline tumor FDG uptake on progression free survival and overall survival. 3. To compare tumoral metabolic progression index to classical clinico-biologic assessment of prognosis (alkaline phosphatase, platelets count, LDH, tumor bulk) 4. To test the prognostic value of MRI based apparent diffusion coefficient (ADC) and variation of vADC based on voxel-based diffusion maps. ;Timepoint(s) of evaluation of this end point: 1. At baseline and after two weeks to be correlated with the patient progression free survival. 2. At baseline and to be correlated with the patient progression free survival and overall survival. 3. At baseline and after two weeks to be correlated with the patient overall survival. 4. At baseline and after two weeks to be correlated with the patient progression free survival and overall survival. | — |
Countries
Belgium
Contacts
Public ContactAmélie Deleporte
Jules Bordet Institute
Outcome results
None listed