Identification of New Patient Stratification Tools in MSS RAS mt mCRC

Advanced Colorectal Cancer Clinical Trial

— COLOSSUS  

Official title:

Identification of New Patient Stratification Tools in Microsatellite Stable (MSS) RAS mt Metastatic Colorectal Cancer (mCRC) - COLOSSUS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699111
• Other study ID #: CTRIAL-IE 17-26
• Status: Completed
• Start date: September 19, 2018
• Est. completion date: April 3, 2022

Study information

• Verified date: November 2022
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 3, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Germany	Private Practice Oncology, Heidelberg	Heidelberg
Germany	University Hospital, Mannheim	Mannheim
Germany	Private Practice Oncology, Speyer	Speyer
Ireland	Bon Secours Hospital, Cork	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	St Vincent's University Hospital	Dublin
Ireland	Tallaght University Hospital	Dublin
Ireland	University Hospital Galway	Galway
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Catala d'Oncologia	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Countries where clinical trial is conducted

Germany,  Ireland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stratification Tools	Identification and technical (analytical) validation of new patient stratification tools (COLOSSUS subtypes) in MSS RAS mt mCRC using a novel integrative systems biomedicine multi-omics discovery framework.	4 years