Clinical trial NCT03031444: Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis
Official title: A Multicenter Study of Prognosis and the Efficacy Comparison of Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Patients(Clinical Risk Score≥3) of Resectable Colorectal Liver Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer Stage IV
Metastasis
Keywords: colorectal liver metastasis
preoperative
chemotherapy
targeted therapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
name: West China Hospital
name: Zhejiang Cancer Hospital
name: First Affiliated Hospital of Kunming Medical University
First posted: 2017-01-25
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: disease free survival
timeFrame: 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
Secondary outcomes:
measure: overall survival
timeFrame: 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
measure: objective response rate
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Cancer Hospital,Peking University
name: Baocai Xing, MD
role: STUDY_DIRECTOR
References:
citation: Primrose J, Falk S, Finch-Jones M, Valle J, O'Reilly D, Siriwardena A, Hornbuckle J, Peterson M, Rees M, Iveson T, Hickish T, Butler R, Stanton L, Dixon E, Little L, Bowers M, Pugh S, Garden OJ, Cunningham D, Maughan T, Bridgewater J. Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. Lancet Oncol. 2014 May;15(6):601-11. doi: 10.1016/S1470-2045(14)70105-6. Epub 2014 Apr 7.
citation: Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.