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

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ClinicalTrials.gov Identifier: NCT03031444
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
Beijing Municipal Administration of Hospitals
West China Hospital
Zhejiang Cancer Hospital
The First Affiliated Hospital of Kunming Medical College
Information provided by (Responsible Party):
Wang Kun, Beijing Cancer Hospital

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Stage IV Metastasis Drug: Cetuximab plus FOLFIRI/FOLFOX Drug: FOLFIRI/FOLFOX/CapeOX Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Active Comparator: chemotherapy plus cetuximab
Cetuximab plus FOLFIRI/FOLFOX:FOLFIRI plus cetuximab [Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1;Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1;5-fluoruracil(5-FU) 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion.Repeat every 2 weeks.Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks] or FOLFOX plus Cetuximab [Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks]
Drug: Cetuximab plus FOLFIRI/FOLFOX
cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy
Other Names:
  • Erbitux
  • C225

Active Comparator: perioperative chemotherapy alone
FOLFIRI/FOLFOX/CapeOX:routine perioperative chemotherapy including FOLFIRI[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1 5-FU 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks] or FOLFOX[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1;Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks] or CapeOX[Oxaliplatin 130 mg/m2 IV over 2 hours, day 1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks] was adopted in this control arm.
Drug: FOLFIRI/FOLFOX/CapeOX
to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)
Other Name: XELOX




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031444


Contacts
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Contact: Kun Wang, MD 86-010-88196559 wang-kun@vip.sina.com
Contact: Kemin Jin, MD 86-010-88196098 ke_min_jin@sina.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Kun Wang, MD    86-010-88196559    wang-kun@vip.sina.com   
Sub-Investigator: Kemin Jin, MD         
Sub-Investigator: Da Xu, MD         
Sub-Investigator: Jian Li, MD         
Sub-Investigator: Yunfeng Yao, MD         
Sub-Investigator: Ming Liu, MD         
Sub-Investigator: Baocai Xing, MD         
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Meng Qiu, MD         
China, Yunnan
First Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China, 650032
Contact: Wenliang Li, MD         
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jieer Ying, MD         
Sponsors and Collaborators
Beijing Cancer Hospital
Beijing Municipal Administration of Hospitals
West China Hospital
Zhejiang Cancer Hospital
The First Affiliated Hospital of Kunming Medical College
Investigators
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Study Director: Baocai Xing, MD Beijing Cancer Hospital,Peking University
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Wang Kun, associate director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03031444    
Other Study ID Numbers: PX2016002
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wang Kun, Beijing Cancer Hospital:
colorectal liver metastasis
preoperative
chemotherapy
targeted therapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms
Neoplastic Processes
Pathologic Processes
Leucovorin
Cetuximab
Fluorouracil
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances