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NCT Number: NCT03031444

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

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.

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Key information

Conditions

Colorectal Cancer Stage IV Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab plus FOLFIRI/FOLFOX

Drug

cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy

Other names: Erbitux, C225

FOLFIRI/FOLFOX/CapeOX

Drug

to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)

Other names: XELOX

Primary outcomes

  1. disease free survival

    Time frame: 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 outcomes

  1. overall survival

    Time frame: 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

  2. objective response rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • Beijing Municipal Administration of Hospitals
  • First Affiliated Hospital of Kunming Medical University
  • West China Hospital
  • Zhejiang Cancer Hospital

Registry information

Official study 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

Acronym: PARECEC

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2017
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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