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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Jules Bordet Institute
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01591590
First received: May 2, 2012
Last updated: January 11, 2016
Last verified: December 2015
  Purpose
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.

Condition Intervention Phase
Colorectal Cancer
Other: FDG PET-CT
Other: Diffusion MRI
Other: Blood samples (plasma preparation and CTC)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour Progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Patients
This is an Interventional, Non Therapeutic arm
Other: FDG PET-CT
All patients will undergo FDG PET-CT at inclusion and 2 weeks after
Other Name: Metabolic Investigation
Other: Diffusion MRI
All patients will undergo Diffusion MRI at inclusion and 2 weeks later
Other Name: Metabolic Investigation
Other: Blood samples (plasma preparation and CTC)

Detailed Description:

Natural history of tumors is a poorly studied subject, the clinical evidence of some tumors aggressiveness as opposed to some other's indolent behavior has never been formally assessed in daily practice or in clinical studies and remains largely unpredictable. The patient's populations are in fact a mix between different tumoral phenotypes that while carrying the same apparent disease evolve with different outcomes.

We hypothesize that,in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.

If the hypothesis is verified, this finding could:

  • Allow to define therapeutic strategies according to the tumoral metabolic progression index.
  • Limit the need for randomization in the early drug development phases as each patient could be considered as his own control.
  • To stratify patients according to their baseline metabolic growth rate in randomized controlled trials with overall survival as an endpoint.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591590

Contacts
Contact: Amélie Deleporte, MD +32 0 2 541 35 41 amelie.deleporte@bordet.be
Contact: Patrick Flamen, MD, PHD +32 0 2 541 37 17 patrick.flamen@bordet.be

Locations
Belgium
Jules Bordet Institute Recruiting
Brussels, Belgium, 1000
Contact: Amélie Deleporte, MD    +32 0 2 541 35 41    amelie.deleporte@bordet.be   
Contact: Patrick Flamen, MD,PHD    +32 0 2 541 37 17    patrick.flamen@bordet.be   
Sub-Investigator: Alain Hendlisz, MD         
Sub-Investigator: Patrick Flamen, MD, PHD         
Sub-Investigator: Jean-Luc Engelholm, MD         
Sub-Investigator: Godelieve Machiels, MD         
Sub-Investigator: Angelique Covas, MD         
Sub-Investigator: Camilo Garcia, MD, ORILAB         
Sub-Investigator: Bruno Vanderlinden, Physicist         
Sub-Investigator: Thomas Guiot, Ir ORILAB         
Sub-Investigator: Hazem El Mansy, MD         
Sub-Investigator: Marc Lemort, MD         
Sub-Investigator: Laura Belenguer Querol, Ir, ORILAB         
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Principal Investigator: Amélie Deleporte, MD Jules Bordet Institute , Universite Libre De Bruxelles
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01591590     History of Changes
Other Study ID Numbers: CORIOLAN  2011-006280-21 
Study First Received: May 2, 2012
Last Updated: January 11, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Jules Bordet Institute:
Colorectal Cancer
Cancer
Colon Cancer
Rectal Cancer
PET
PET-CT
MRI
Diffusion MRI
Apparent Diffusion Coefficient
ADC
Metabolic Progression Index

Additional relevant MeSH terms:
Colorectal Neoplasms
Disease Progression
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2016