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

Phase 3

Completed

• Conditions: Liver metastases colorectal cancer; 10019815; 10017998

• Registration Number: NL-OMON44796
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 224

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: overall survival (OS), calculated from the date of<br /><br>randomization to the date of death from any cause of the patient</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Besides OS, we will evaluate PFS of the patients included in the study. PFS<br /><br>will be defined counting from the date of randomization to the first event<br /><br>defined as local recurrence or progression, distant recurrence or death from<br /><br>any cause. Furthermore:<br /><br>* To determine quality of life in the two study arms<br /><br>* To determine treatment response on neoadjuvant chemotherapy<br /><br>* To compare morbidity of surgery and resection rate between the 2 arms<br /><br>* To evaluate whether CEA can predict for treatment response, PFS and OS</p><br>