eo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastasesThe CHARISMA randomized multicenter clinical trial - CHARISMA

Erasmus MC Cancer Institute0 sites224 target enrollmentJuly 23, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 23, 2014

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Erasmus MC Cancer Institute

•Age \= 18 years.
•ECOG performance status 0 or 1\.
•Histologically confirmed primary colorectal carcinoma. Primary colorectal carcinomas to be included are:
•1\. Previously resected histologically proven colorectal carcinoma
•2\. Coloncarcinoma still in situ, deemed suitable for resection at the time of liver surgery
•3\. Rectal carcinoma still in situ, requiring no neo\-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
•4\. 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.
•Clinical risk score of 3\-5 (Fong et al.).
•Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 15 days prior to randomization.

•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.
•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 or interfering with compliance for oral drug intake.
•Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (\= 6 months prior to randomization), myocardial infarction (\= 1 year prior to randomization), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhytmia requiring medication.
•Serious, non\-healing wound, ulcer, or bone fracture.
•Serious intercurrent infections (uncontrolled or requiring treatment).