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A Population-based Prospective Study of Metastatic Colorectal Cancer (CRC) Patients in Finland (RAXO)

This study is currently recruiting participants.
Verified February 2012 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Pia Osterlund, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01531621
First received: February 3, 2012
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose
  • A population-based prospective study to evaluate clinical behaviour, resectability and survival in 1st line metastatic colorectal cancer (CRC) patients in Finland
  • Primary objective: To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
  • Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy and targeted drugs with overall response rates (ORR), failure free survival (FFS), progression free survival (PFS), and overall survival (OS); To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and tumour block biomarkers and DNA polymorphisms that may predict drug effects, resectability and clinical behaviour of the tumour

Condition Intervention
Metastatic Colorectal Cancer
 Other: Biomarker sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Population-based Prospective Study to Evaluate Clinical Behaviour, Resectability and Survival in 1st Line Metastatic Colorectal Cancer (CRC) Patients in Finland

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Resectability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Response rates

  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Number of adverse events

  • Radiological assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria


Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
mCRC treatments
All used treatments for metastatic colorectal cancer
 Other: Biomarker sampling
Blood samples every 8-12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with metastatic cancer of the colon or rectum

Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease
  2. Age > 18
  3. Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy)
  4. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to study
  5. No informed consent will be obtained from patients participating in the data collection study obtaining data from hospital charts. No blood sampling, nor contacting of patients will be performed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531621

Contacts
Contact: Pia Osterlund, MD +358-9-4711 pia.osterlund@hus.fi

Locations
Finland
Department of Oncology Recruiting
Helsinki, Finland
Contact: Pia Osterlund, MD     +358-9-4711     pia.osterlund@hus.fi    
Principal Investigator: Pia Osterlund, MD            
Principal Investigator: Helena Isoniemi, MD            
Sponsors and Collaborators
Pia Osterlund
Investigators
Principal Investigator: Pia Osterlund, MD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Pia Osterlund, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01531621     History of Changes
Other Study ID Numbers: 2011-003158-24
Study First Received: February 3, 2012
Last Updated: February 10, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013