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Study of Cetuximab in Combination With Chemotherapy for the First Treatment of Metastatic Colorectal Cancer

Phase 4
18 Years
75 Years
Open (Enrolling)
Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms

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Trial Information

Study of Cetuximab in Combination With Chemotherapy for the First Treatment of Metastatic Colorectal Cancer

Patients will be eligible for inclusion if their primary tumors have been resected and if
the patients have histologically confirmed wild-type-KRAS colorectal adenocarcinoma with
synchronous liver-confined metastases deemed non-resectable. Eligible patients will be
randomly assigned to chemotherapy plus cetuximab (arm A) or chemotherapy alone (arm B).
Treatment will be planned to commence between 2 and 4 weeks after the primary surgery.
Treatment will continue until tumor response indicates suitability for surgery for liver
metastases or until disease progression or unacceptable toxic effects. The primary endpoint
is the conversion rate to radical resection for liver metastases,which will be assessed by
local multidisciplinary team (includes more than three liver surgeons and one radiologist)
with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 2 cycles up
to 12 cycles. To provide an objective assessment of changes in resectability, radiological
images will be presented by a radiologist to more than 3 liver surgeons, who are blinded to
the clinical data. Patients will be considered resectable if 50% or more of surgeons vote
for radical resection of LM. For patients whose liver-metastases are assessed resectable,
resection should be scheduled to be performed within 2~3 weeks of the last treatment cycle.
Following resection, patients will be advised to continue the same therapeutic regimen until
the treatments reach a sum of 12 cycles.

Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;

2. Primary tumour has undergone radical resection and histologically confirmed
colorectal adenocarcinoma;

3. Together with clinical or radiological evidence of first occurrence of non-resectable
synchronous liver-only metastases

4. With evidence of tumor EGFR expression and KRAS gene wild-type status;

5. With one measurable tumor.

6. Performance status (ECOG) 0~1

7. A life expectancy of ≥ 3 months

8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100
x109/l; Hb ≥9g/dl (within 1 week prior to randomization)

9. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal
(ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x
ULN(within 1 week prior to randomization);

10. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Previous exposure to target therapy, chemotherapy, radiotherapy or intervention
therapy for colorectal liver metastases.

2. Known or suspected extrahepatic metastases.

3. Patients with known hypersensitivity reactions to any of the components of the study

4. Having previously participated in a study which included a possibility of being
allocated to cetuximab therapy (whether or not the patient actually received

5. Clinically relevant coronary artery disease or a history of a myocardial infarction
within the last 12 months or left ventricular ejection fraction (LVEF) below the
institutional range of normal

6. Acute or sub-acute intestinal occlusion

7. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding

8. Other previous malignancy within 5 years, with exception of a history of a previous
basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

9. Known drug abuse/ alcohol abuse

10. Legal incapacity or limited legal capacity

11. Pre-existing peripheral neuropathy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the rate of patients converted to resection for liver metastases

Outcome Description:

To explore whether cetuximab in combination with chemotherapy as treatment could improve the resection rate in patients with KRAS wild-type, unresectable colorectal liver-limited metastases compared with chemotherapy alone.

Outcome Time Frame:

3 years

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

September 2015

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms
  • liver metastasis
  • colorectal cancer
  • cetuximab
  • chemotherapy
  • Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis