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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)
Other Name: XELOX
- 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
- 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
- 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.
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
|Contact: Kun Wang, MDemail@example.com|
|Contact: Kemin Jin, MDfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Kun Wang, MD 86-010-88196559 email@example.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|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Meng Qiu, MD|
|First Affiliated Hospital of Kunming Medical University||Recruiting|
|Kunming, Yunnan, China, 650032|
|Contact: Wenliang Li, MD|
|Zhejiang Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310022|
|Contact: Jieer Ying, MD|
|Study Director:||Baocai Xing, MD||Beijing Cancer Hospital,Peking University|