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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Colorectal Cancer Stage IV Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type ACTIVE_COMPARATOR

Cetuximab plus FOLFIRI/FOLFOX

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

FOLFIRI/FOLFOX/CapeOX

Intervention Type DRUG

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

Interventions

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Cetuximab plus FOLFIRI/FOLFOX

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

Intervention Type DRUG

FOLFIRI/FOLFOX/CapeOX

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

Intervention Type DRUG

Other Intervention Names

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Erbitux C225 XELOX

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No