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Randomized Phase 2 Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Treatment Combining Cetuximab With FOLFOX or FOLFIRI in KRAS-Wild-Type Tumors

Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

Randomized Phase 2 Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Treatment Combining Cetuximab With FOLFOX or FOLFIRI in KRAS-Wild-Type Tumors

After the patient inclusion (ICF signed, screening period), the patient will be randomized
into one of the two arms, and he will begin the treatment. After 6 cycles of treatment he
will support a metastases resection and after a rest period he will started an another
treatment period (decided or not by local investigator due to the result of the previous
treatment). After he will enter in the follow up period during 33 month. The follow up
period began maximum 3 months after the post operative period and takes end 33 month after
post operative period.

Inclusion Criteria:

- 1. Female or male patients with at least 18 years at the time the informed consent is
signed 2. ECOG performance status 0 or 1 3. Histological or cytological confirmed
diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour
in situ. Wild-type KRAS tumor status.

4. Patients must present a resectable metastatic disease for which the decision of
preoperative chemotherapy is considered. Resectability could be planed in one or
multiple stage if indicated. As commonly admitted, resectability means the surgical
clearance (+/- radiofrequency ablation) of all detectable (liver) lesions with
tumor-free margins and compatible with an adequate hepatic reserve. Practically,
bilateral tumor location, number and location of lesions, and inadequate hepatic
reserve remain the main decisional factors.

5. Partial and minor resection of metastatic disease is allowed within 3 months
before inclusion if patient has never received chemotherapy for mCRC.

6. Extra hepatic metastatic location is limited to 1 site. Extra-hepatic location
must be easily resectable in one stage surgery.

7. Patients may have received adjuvant chemotherapy or (neo-) adjuvant
chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was
administered at least 6 months prior to inclusion (12 months for oxaliplatin).
Previous radiotherapy to the pelvis is not an exclusion criterion.

8. Adequate haematological, renal and hepatic function as follows: Haematological
Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L Renal Creatinine < 1.5 x ULN
(Upper Limit of Normal) Hepatic Bilirubin < or equal 1.5 X ULN AST (Aspartate
Aminotransferase), ALT (Alanine Aminotransferase) Phos Alc < or equal 3 x ULN < or
equal 5 x ULN

9. Female patients must either be postmenopausal, sterile (surgically or radiation-
or chemically-induced), or if sexually active using an acceptable method of

10. Male patients must be surgically sterile or if sexually active and having a
pre-menopausal partner must be using an acceptable method of contraception.

11. Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria:

- 1. Non resectable mCRC (metastatic ColoRectalCancer)(if resectability remains
uncertain or unprobable after 3 months chemotherapy, patient is excluded from the

2. Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for
colorectal cancer is not an exclusion criterion provided that it was completed more
than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed
more than 1 year prior to inclusion.

3. Prior utilization of cetuximab, panitumumab (or other anti-EGFR (epidermal growth
factor receptor)therapy).

4. Previous radiotherapy delivered to the upper abdomen. 5. Evidence of ascites,
cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis
as determined by clinical or radiologic assessment.

6. Prior major liver resection: remnant liver < 50% of the initial liver volume.

7. Non-malignant disease that would render the patient unsuitable for treatment
according to this protocol.

8. Concurrent central nervous systems metastases 9. Peripheric neuropathy ≥ grade 2.
10. Interstitial lung disease 11. Pregnant or breast feeding. 12. The patient has
previous or concomitant malignancies, except: Invasive malignancies in remission for
more than 5 years and non melanoma skin cancer or carcinoma in situ of the cervix.

Type of Study:


Study Design:

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

Outcome Measure:

Major Pathological Response Rate

Outcome Description:

This is at the surgery time. The metastases resection must be process after 6 cycles of randomized chemotherapy + target therapy. It depend but it will be normally 3 months after patient inclusion in the study

Outcome Time Frame:

Average 3 months (after resection of metastases)

Safety Issue:


Principal Investigator

Marc Van den Eynde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques universitaires Saint-Luc - UCL


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • metastatic
  • colorectal
  • cancer
  • Liver
  • cetuximab
  • Pathological response
  • Colorectal Neoplasms
  • Neoplasm Metastasis