Perioperative chemotherapy with FOLFOX plus Cetuximab versus adjuvant FOLFOX plus Cetuximab for patients with resectable liver metastases of colorectal carcinoma - Panter-study

Conditions: resectable liver metastases of colorectal carcinoma with proven K-RAS wildtype

Registration Number: EUCTR2008-005312-41-AT

Lead Sponsor: RWTH Aachen University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 430

Inclusion Criteria

1.Signed written informed consent obtained prior to any study-specific procedure
2.Age = 18 years, full contractual capability
3.Proven K-RAS wildtype in primary tumour or metastasis tissue
4.Diagnosis of metachronous metastases after complete resection (R0) of primary tumour without gross or microscopic evidence of residual disease.
or
Diagnosis of synchronous metastases after complete resection (R0) of primary tumour more than 1 month before study.
or
Diagnosis of synchronous metastases with sufficient evidence (i.e., CT scan or diagnostic laparoscopy) that both the primary tumour and liver metastases can be completely resected during the same procedure and resection of primary tumour may be delayed 3-4 months
5.Negative pregnancy test
6.Highly effective contraception during treatment and for at least 3 months thereafter in women (defined as pearl index < 1), if necessary also for partners of test persons, complete abstinence of intercourse (during study participation and follow-up time)
7.Planned start of study medication between 0 and 3 weeks post randomization
8.ECOG performance status 0 or 1 (Appendix 1)
9.Adequate hematology: neutrophils > 1.5 /nl, platelets > 100/nl, INR < 1.5, aPTT < 1.5 x UNL
10.Adequate biochemistry: total bilirubin < 1.5 x UNL, ASAT and ALAT < 5 x UNL, alkaline phosphatase < 5 x UNL, serum creatinine < 1.5 x UNL

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with any relationship of dependence to the sponsor or the investigator
2.Patients committed to an institution (court-ordered or by official orders)
3.Extrahepatic metastatic disease
4.Proven K-RAS mutation or unknown K-RAS mutational status in tumour tissue.
5.Oxaliplatin-based adjuvant chemotherapy within 1 year before randomization.
6.Neuropathy = grade 3 (NCI-CTC V4.0) during prior oxaliplatin-based chemotherapy.
7.Any prior chemotherapy for metastatic disease.
8.Previous treatment with EGFR antibodies.
9.Prior non-colorectal malignancies, except adequately treated basalioma of the skin or carcinoma in situ of the cervix.
10.Bleeding diathesis or coagulation disorders
11.Females with a positive pregnancy test (within 14 days before treatment start) or breast feeding.
12.Fertile women (< 2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception
13.History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for drug intake.
14.Clinically significant (i.e. active) cardiovascular disease, e.g. cerebrovascular accidents (<6 months prior to randomization), myocardial infarction (<1 year prior to randomization), Congestive heart failure (NYHA Grades III or IV), uncontrolled hypertension while receiving chronic medication, unstable angina pectoris, significant arrhythmia.
15.Known peripheral neuropathy, including oxaliplatin-induced neuropathy = grade 1 (NCI-CTC V4.0). Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.
16.Known DPD-deficiency (Dihydropyrimidine dehydrogenase).
17.Organ allografts requiring immunosuppressive therapy.
18.Serious non-healing wound, ulcer or bone fracture.
19.Serious intercurrent infections (uncontrolled or requiring treatment).
20.Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study.
21.Any contraindications against study medication (including auxiliary substances).
22.Patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons.