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Trial Title:
Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM
NCT ID:
NCT05948072
Condition:
Colorectal Cancer
Liver Metastases
Conditions: Official terms:
Neoplasm Metastasis
Cetuximab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
mFOLFOX6 + Cetuximab
Description:
Cetuximab + mFOLFOX6: Cetuximab (500mg/m2 IV ) will be given. Oxaliplatin (85 mg/m2 IV
over 2 h on day 1), Leucovorin calcium (350 mg/m2 IV over 2 h on day 1) plus a bolus of
5FU (400 mg/m2) followed by a 46h-48h IV infusion of 5FU 2400 mg/m2 will be repeated for
every 2 weeks. The regimens repeat every 2 weeks for up to 4 courses in the absence of
disease progression or unacceptable toxicity.
Arm group label:
mFOLFOX6 + Cetuximab
Intervention type:
Drug
Intervention name:
mFOLFOX 6
Description:
mFOLFOX6: Oxaliplatin (85 mg/m2 IV over 2 h on day 1), Leucovorin calcium (350 mg/m2 IV
over 2 h on day 1) plus a bolus of 5FU (400 mg/m2) followed by a 46h-48h IV infusion of
5FU 2400 mg/m2 will be repeated for every 2 weeks. The regimens repeat every 2 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm group label:
mFOLFOX6
Summary:
For patients with initially resectable colorectal cancer liver metastases who have
high-risk factors, neoadjuvant therapy is currently considered a consensus approach.
However, there is ongoing debate regarding the optimal treatment strategy. Our study aims
to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves
outcomes compared to neoadjuvant chemotherapy alone. The objective of this phase III
clinical trial is to determine whether the combination of cetuximab and mFOLFOX6
chemotherapy is superior to neoadjuvant mFOLFOX6 chemotherapy alone for patients with
initially resectable colorectal cancer liver metastases who have wild-type RAS/BRAF and
high-risk factors.
Detailed description:
Primary
• To determine whether the addition of cetuximab to neoadjuvant mFOLFOX6 chemotherapy
results in improved event-free survival when compared with neoadjuvant mFOLFOX6
chemotherapy alone in patients with high-risk & RAS/BRAF-wild-type & resectable
colorectal liver metastases.
Secondary
- To evaluate the overall survival of patients treated with these regimens.
- To evaluate the quality of life of patients treated with these regimens.
- To evaluate the preoperative remission rate, safety, surgical complications, actual
resection rate, pathological resection status of patients treated with these
regimens.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histological proof of colorectal adenocarcinoma;
2. Age ≥ 18 years and ≤75 years;
3. RAS wild type；
4. CRS≥3；
5. Simultaneous liver-limited metastases;
6. At least one measurable liver metastases;
7. World Health Organization (WHO) performance status 0-1;
8. Life expectancy ≥ 3 months;
9. Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l,
platelets≥100×109/l, and hemoglobin(HB) ≥ 9g/dl;
10. Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤
5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine
clearance ≥ 30 ml/min;
11. Written informed consent.
Exclusion Criteria:
1. Previous systemic treatment for metastatic disease;
2. Previous surgery for metastatic disease;
3. Extrahepatic metastases;
4. Unresectable primary tumor;
5. Major cardiovascular events (myocardial infarction, severe/unstable angina,
congestive heart failure, CVA) within 12 months before randomisation;
6. Acute or subacute intestinal obstruction;
7. Second primary malignancy within the past 5 years;
8. Drug or alcohol abuse;
9. No legal capacity or limited legal capacity;
10. Pregnant or lactating women;
11. Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3
antihypertensive drugs;
12. Peripheral neuropathy;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan hosptial, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Jianmin Xu, PhD
Phone:
+86-13501984869
Email:
xujmin@aiiyun.com
Start date:
July 15, 2023
Completion date:
July 15, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05948072
