NL-OMON44796
Completed
Phase 3
eo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases ;The CHARISMA randomized multicenter clinical trial - CHARISMA
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Liver metastases colorectal cancer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 224
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Age \* 18 years.
- •\* ECOG performance status 0 or 1
- •\* Histologically confirmed primary colorectal carcinoma. Primary colorectal carcinomas to be included are:
- •\* Previously resected histologically proven colorectal carcinoma
- •\* Coloncarcinoma still in situ, deemed suitable for resection at the time of liver surgery
- •\* Rectal carcinoma still in situ, requiring no neo\-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
- •\* Rectal carcinoma still in situ, requiring short\-course neo\-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
- •\* Radiologically confirmed and resectable liver metastasis of colorectal cancer after surgery. Criteria for resectability are outlined in the study protocol.
- •\* Clinical risk score of 3\-5
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
- •\* Locally advanced rectal cancer in situ requiring long\-course pre\-operative chemoradiotherapy
- •\* Major surgical procedure \<4 weeks prior to randomization.
Outcomes
Primary Outcomes
Not specified
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