Colorectal Cancer Stage IV, Metastasis
Conditions
Keywords
colorectal liver metastasis, preoperative, chemotherapy, targeted therapy
Brief summary
This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis. The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.
Detailed description
Resection could prolong the survival of colorectal liver metastasis patients, however,the curative resection rate was still low and more than 2/3 of the patients would experience tumor recurrence.This study was designed to formulate a more accurate and individual evaluation system via the multivariate analysis. Up to now, there was no data to demonstrate the addition of cetuximab to perioperative chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was also designed to elucidate this question and to observe the objective response rate(ORR) and the safety data of the regime.
Interventions
DRUGCetuximab plus FOLFIRI/FOLFOX
cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy
DRUGFOLFIRI/FOLFOX/CapeOX
to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)
Sponsors
Beijing Municipal Administration of Hospitals
West China Hospital
Zhejiang Cancer Hospital
First Affiliated Hospital of Kunming Medical University
Peking University Cancer Hospital & Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* good performance status * pathologic diagnosis of colorectal cancer * Rat sarcoma viral oncogene homolog(RAS) wild-type * radiologic confirmation the resectability of liver metastases * enough future liver remnant * Clinical Risk Score≥3 * treatment naive * extra-hepatic metastases could be resected completely, if exist
Exclusion criteria
* poor performance status, could not tolerate chemotherapy or operation * other malignancy history or synchronously * extra-hepatic metastases could not be resected completely, if exist * received other treatment previously
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | From date of hepatectomy until the date of first documented recurrence or metastasis or date of death from any cause, whichever came first, assessed up to 60 months | months the patient lived from the date of liver resection to the date of disease recurrence or metastasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | From date of hepatectomy until the date of first documented death from any cause or the last follow-up if no death happened, assessed up to 60 months | months the patient lived from the date of liver resection to the date of patient death |
| objective response rate | from the date of the first chemotherapy until the date two weeks after the completion of the last preoperative chemotherapy, assessed up to 6 weeks | percent of the number of patients who showed partial response(PR) or complete response(CR) who received preoperative chemotherapy to the number of all the patients enrolled. |
Countries
China
Outcome results
None listed