Clinical trial NCT03699111: Identification of New Patient Stratification Tools in MSS RAS mt mCRC
Official title: Identification of New Patient Stratification Tools in Microsatellite Stable (MSS) RAS mt Metastatic Colorectal Cancer (mCRC) - COLOSSUS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Colorectal Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2018-10-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with stage IV MSS RAS mutant colorectal cancer

Brief summary: This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer

Detailed description: The rational of COLOSSUS is to provide new and more effective stratification tools and therapeutic interventions, specifically tailored to MSS RAS mt mCRC patients

Eligibility criteria: Inclusion criteria

Patient Status

1. Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
2. Age ≥ 18 years,
3. ECOG status of ≤ 2,
4. At least 16 weeks of life expectancy at time of entry into the study.

   Disease-related
5. Histologically confirmed stage IV MSS RAS mt mCRC as per standard diagnostic tests,
6. Unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (RECIST v.1.1),
7. No prior chemotherapy and/or radiation therapy for CRC administered in the metastatic setting,
8. Scheduled to receive or receiving SOC chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab (baseline blood sample should be collected and questionnaires completed during pre-screening and before chemotherapy initiation),
9. Availability of archival formalin-fixed paraffin-embedded (FFPE) tissue from:

   1. Preferred: surgical resection of the primary or metastatic tumour

      or
   2. Biopsy samples (biopsy taken at endoscope, needle core or surgical incision or excision) obtained from the primary or metastatic tumour.

The archival FFPE tissue blocks must be obtained during initial diagnosis (before patient was exposed to any chemotherapy and/or radiation therapy).

Exclusion Criteria

1. Patient with CRC that has received any therapy for CRC before:

   1. surgical resection of tissue that would be utilised in this study

      or
   2. biopsy procedure for tissue that would be utilised in this study,
2. Patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration,
3. Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent,
4. Patient with clinical or laboratory contraindication to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin.

Primary outcomes:
measure: Stratification Tools
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Private Practice Oncology, Heidelberg
city: Mannheim
country: Germany
facility: University Hospital, Mannheim
city: Speyer
country: Germany
facility: Private Practice Oncology, Speyer
city: Cork
country: Ireland
facility: Bon Secours Hospital, Cork
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia
Study officials:
References: