Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis

Metastasis Clinical Trial

— PARECEC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031444
• Other study ID #: PX2016002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Metastasis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• Cetuximab plus FOLFIRI/FOLFOX
cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy
• FOLFIRI/FOLFOX/CapeOX
to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Beijing Municipal Administration of Hospitals, The First Affiliated Hospital of Kunming Medical College, West China Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. Erratum in: Lancet Oncol. 2014 Jun;15(7):e253. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	months the patient lived from the date of liver resection to the date of disease recurrence or metastasis	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	overall survival	months the patient lived from the date of liver resection to the date of patient death	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
Secondary	objective response rate	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.	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

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