resectable liver metastases of colorectal carcinoma with proven K-RAS wildtype MedDRA version: 18.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: L01XC06
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Concentration unit: mg/ml milligram(
Sponsors
RWTH Aachen University
Eligibility
Sex/Gender
All
Inclusion criteria
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 1.5 /nl, platelets > 100/nl, INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first primary objective of the study is to compare the postoperative complication rate according to Clavien score (> grade 1) of a perioperative chemotherapy with a postoperative regimen. A second primary objective of the study is to compare for the patient subgroup with >3 liver metastases or at least one metastasis = 5 cm in diameter the median disease free survival. ;Secondary Objective: • To compare the overall disease-free survival. • To compare the overall survival. • To compare operation, resection and R0 rates. • To compare the safety and chemotherapy-associated toxicity (NCI-CTC V4.0) • To compare the effect of a perioperative therapy on health-related quality of life (EORTC QLQ-C30 + QLQ-LMC21). • To compare the number of cycles, dose intensity and dose modifications applied. • To evaluate the response rate (RECIST V1.1 no confirmation of response needed) after preoperative chemotherapy. • Resected liver mass ;Primary end point(s): The first primary objective of the study is to compare the postoperative complication rate according to the Clavien score (> grade 1) (Appendix 2) of a perioperative chemotherapy with a postoperative regimen. A second primary objective of the study is to compare for the patient subgroup with > 3 liver metastases or at least one metastasis = 5 cm in diameter the median disease free survival between the two treatment arms | — |
Countries
Austria, Germany
Outcome results
None listed