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

• Sponsor: Pia Osterlund (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01531621
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Duration (Months): 166
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

• 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 or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Other: Biomarker sampling

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• 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
• Study Start Date: Feb 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
mCRC treatments All used treatments for metastatic colorectal cancer	Other: Biomarker sampling; Blood samples every 8-12 weeks

Outcome Measures

Primary Outcome Measures

1. Resectability [5 years]

   To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection

Secondary Outcome Measures

1. Efficacy [5 years]

   Response rates

2. Safety [5 years]

   Number of adverse events

3. Radiological assessment [5 years]

   To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology	Helsinki		Finland

Sponsors and Collaborators

• Pia Osterlund

Investigators

• Principal Investigator: Pia Osterlund, MD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pia Osterlund, Principal Investigator, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT01531621
• Other Study ID Numbers: 2011-003158-24
• First Posted: Feb 13, 2012
• Last Update Posted: Mar 26, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Pia Osterlund, Principal Investigator, Helsinki University Central Hospital: metastatic colorectal cancer
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Mar 26, 2015