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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 March 2015 by Pia Osterlund, Helsinki University Central Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531621
First Posted: February 13, 2012
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pia Osterlund, Helsinki University Central Hospital
  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:


Further study details as provided by Pia Osterlund, Helsinki University Central Hospital:

Primary Outcome Measures:
  • Resectability [ Time Frame: 5 years ]
    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 ]
    Response rates

  • Safety [ Time Frame: 5 years ]
    Number of adverse events

  • Radiological assessment [ Time Frame: 5 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pia Osterlund, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01531621     History of Changes
Other Study ID Numbers: 2011-003158-24
First Submitted: February 3, 2012
First Posted: February 13, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Pia Osterlund, 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