NL-OMON50622
Recruiting
Not Applicable
Determination of new biomarkers in patients with resectable colorectal liver metastases, the MIRACLE study - MIRACLE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- colorectal liver metastases
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 240
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>\= 18 years.
- •Histologically confirmed primary colorectal carcinoma.
- •Radiological confirmed and resectable liver metastasis of colorectal cancer,
- •planned to undergo resection with or without neo\-adjuvant chemotherapy.
- •Before patient registration, written informed consent must be given according
- •to ICH/GCP, and national/local regulations.
Exclusion Criteria
- •Prior adjuvant chemotherapy for the primary colorectal carcinoma given \<6
- •months prior to detection of the liver metastases.
- •Prior non colorectal malignancies, except for patients with basal or squamous
- •cell carcinoma of the skin, or patients with carcinoma in situ of the cervix.
- •Presence of extrahepatic disease. Patients with small (\<\=1 cm) extrahepatic
- •lesions that are not clearly suspicious of metastases are eligible.
- •Females with a positive pregnancy test (within 14 days before treatment start).
- •History of psychiatric disability judged by the investigator to be clinically
- •significant, precluding informed consent.
- •Current or recent treatment with another investigational drug or participation
Outcomes
Primary Outcomes
Not specified
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