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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44796

Enrollment

224

Registered

2014-07-23

Start date

2014-10-22

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver metastases colorectal cancer

Interventions

Patients will be randomized into one of two groups. One group will be treated by surgery for the liver metastases only (standard treatment, arm 1). The other group will be treated by neo-adjuvant ox

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria: * Prior adjuvant chemotherapy for the primary colorectal carcinoma given

Design outcomes

Primary

Measure	Time frame
Primary endpoint: overall survival (OS), calculated from the date of randomization to the date of death from any cause of the patient	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)