Status:
TERMINATED
Treatment Regimens for Patients With Resectable Liver Metastases (PANTER Study)
Lead Sponsor:
RWTH Aachen University
Conditions:
Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Is a perioperative chemotherapy based on FOLFOX and Cetuximab (K-RAS wild-type) associated with a higher rate of postoperative complications in patients with resectable colorectal liver metastases as ...
Detailed Description
In recent years chemotherapy based on FOLFOX and cetuximab has become a standard treatment in patients with colorectal liver metastases. Recently, the analysis of the CELIM trial reported response rat...
Eligibility Criteria
Inclusion
- Signed written informed consent obtained prior to any study-specific procedure.
- Age \> 18 years
- Proven K-RAS wildtype in primary tumour or metastasis tissue
- Diagnosis of resectable metachronous metastases after complete resection (R0) of primary tumour without gross or microscopic evidence of residual disease. or Diagnosis of resectable synchronous metastases after complete resection (R0) of primary tumour more than 1 month before study or Diagnosis of resectable 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 can be delayed 3-4 months.
- Negative pregnancy test
- Highly effective contraception during treatment and for at least 3 months thereafter in women (defined as pearl index \< 1) and men, if the risk of conception exists
- Planned start of study medication between 0 and 3 weeks post randomization
- ECOG performance status 0 or 1 (Appendix 1)
- Adequate hematology: neutrophils \> 1,5 /nl, platelets \> 100/nl, INR \< 1,5, aPTT \< 1,5 x UNL
- 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.
Exclusion
- Patients with any relationship of dependence to the sponsor or the investigator
- Patients committed to an institution (court-ordered or by official orders)
- Extrahepatic metastatic disease
- Proven K-RAS mutation or unknown K-RAS mutational status in tumour tissue
- Oxaliplatin-based adjuvant chemotherapy within 1 year before randomization
- Neuropathy \> or = grade 3 (NCI-CTC V4.0) during prior oxaliplatin-based chemotherapy
- Any prior chemotherapy for metastatic disease
- Previous treatment with EGFR antibodies
- Prior non-colorectal malignancies, except adequately treated basalioma of the skin or carcinoma in situ of the cervix.
- Bleeding diathesis or coagulation disorders
- Females with a positive pregnancy test (within 14 days before treatment start) or breast feeding
- Fertile women (\<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception
- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for drug intake
- 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
- Known peripheral neuropathy, including oxaliplatininduced
- \> or = grade 1 (NCI-CTC V4.0). Absence of deep tendon reflexes being the sole neurologicl abnormality does not render the patient ineligible
- Known DPD-deficiency (Dihydropyrimidinedehydrogenase)
- Organ allografts requiring immunosuppressive therapy
- Serious, non-healing wound, ulcer or bone fracture
- Serious intercurrent infections (uncontrolled or requiring treatment)
- Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study
- Any contraindications against study medication (including auxiliary substances)
- Patients unwilling to consent the saving and propagation of pseudonymized medical data for study reasons
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01266187
Start Date
July 1 2011
End Date
September 1 2015
Last Update
September 22 2015
Active Locations (1)
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1
Department of Surgery, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany, 52074