- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01266187
Treatment Regimens for Patients With Resectable Liver Metastases (PANTER Study)
Perioperative Chemotherapy With FOLFOX Plus Cetuximab Versus Adjuvant FOLFOX Plus Cetuximab for Patients With Resectable Liver Metastases of Colorectal Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- Department of Surgery, University Hospital Aachen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm B
12 weeks FOLFOX + cetuximab -> 4 weeks rest -> surgery -> 4-8 weeks rest -> 12 weeks FOLFOX + cetuximab |
12 weeks FOLFOX + cetuximab -> 4 weeks rest -> surgery -> 4-8 weeks rest -> 12 weeks FOLFOX + cetuximab |
ACTIVE_COMPARATOR: Arm A
surgery -> 4-8 weeks rest -> 24 weeks FOLFOX + cetuximab
|
surgery -> 4-8 weeks rest -> 24 weeks FOLFOX + cetuximab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clavien score (> grade 1)
Time Frame: 1 year
|
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
|
1 year
|
Disease free survival
Time Frame: 1 year
|
A second primary objective of the study is to compare for the patient subgroup with >3 liver metastases or at least one metastasis > or = 5 cm in diameter the median disease free survival.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary objectives
Time Frame: 5 years
|
Secondary Objectives:
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ulf P Neumann, Prof., RWTH Aachen University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Liver Diseases
- Neoplastic Processes
- Neoplasm Metastasis
- Liver Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Immunological
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Cetuximab
Other Study ID Numbers
- CTC-A10-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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