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

Peking University Cancer Hospital & Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metastasis; Colorectal Cancer Stage IV

Treatments: Drug: Cetuximab plus FOLFIRI/FOLFOX; Drug: FOLFIRI/FOLFOX/CapeOX

Study type: Interventional

Funder types: Other

Identifiers

NCT03031444

PX2016002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

chemotherapy plus cetuximab

Active Comparator group

Description:

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 \[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks\]

Treatment:

Drug: Cetuximab plus FOLFIRI/FOLFOX

perioperative chemotherapy alone

Active Comparator group

Description:

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.

Treatment:

Drug: FOLFIRI/FOLFOX/CapeOX