Synchronous or metachronous peritoneal carcinomatosis (PC) from appendiceal or colorectal cancer MedDRA version: 17.1 Level: LLT Classification code 10068069 Term: Peritoneal carcinomatosis System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Other descriptive name: Erbitux
Concentration unit: mg/ml mi
Sponsors
University of Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven wt-RAS colorectal or appendiceal adenocarcinoma - Complete macroscopic cytoreduction (CCR-0/1) - 3-12 cycles of systemic chemotherapy (FOPLFOX/FOLFIRI) including cetuximab as preoperative induction therapy - Availability of CT scan prior to preoperative chmeotherapy allowing for sufficient response evaluation - Age over 18 and below 71 years - Good general health status (Karnofsky > 70%, ECOG 0-2) - Absence of hematogenous metastasis (lung, bone, brain, > 3 peripheric resectable liver metastases) - Absence of contraindication for systemic chemotherapy and/or extended surgery - Life expectancy greater than 6 months - Written informed consent - Creatinine clearance > 50 ml/min, serum creatinine = 1.5 x ULN - Serum bilirubin = 1.5 x ULN (upper limit of normal), ASAT and ALAT = 2.5 x ULN - Platelet count > 100,000 /ml, haemoglobin > 9 g/dl, neutrophile granulocytes = 1,500 /ml, International Normalized Ration (INR) = 2 - Absence of peripheral neuropathy > grade 1 (CTCAE v4.0) - No pregnancy or breast feeding. Adequate contraception in fertile patients. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Incomplete cytoreduction, tumordebulking, palliative surgery - Hematogenous metastasis including irresectable liver metastasis - Chemotherapy or therapy with EGFR receptor antibody for metastatic disease prior to actual induction therapy - RAS mutation (exon 2,3 and 4 or KRAS and NRAS) or unknown RAS statuts - Known allergy to murine or chimeric monoclonal antibodies - Histology of signet ring carcinoma (> 20%) - Other malignancy than disease under study / second cancer < 5 years after R0 resection -Impaired liver, renal or hematologic function as mentioned above (inclusion criteria) - Heart failure NYHA = 2 or significant Coronary Artery Disease - Alcohol and/or drug abuse - Patients unable or unwilling to comply with the study protocol, treatment or follow-up - Patients included in other clinical trials interfering with the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect as assessed by progression-free survival (PFS) of the following treatment regimen: CRS and HIPEC with Oxaliplatin and simultaneous intravenous 5-FU/LV with preoperative (and postoperative) systemic multidrug chemotherapy including cetuximab.;Secondary Objective: To evaluate - overall survival (OS) - perioperative morbidity and chemotherapy related toxicity - feasibility of the combined treatment concept - quality of life (QoL) - pathohistological regression after neoadjuvant treatment To establish a tissue bank for translational research. ;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: time of occurence during the 8-9 months treatment or the 2-year follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) overall survival (OS) 2) perioperative morbidity and chemotherapy related toxicity 3) feasibility of the combined treatment concept 4) quality of life (QoL) 5) pathohistological regression after neoadjuvant treatment;Timepoint(s) of evaluation of this end point: 1) time of death during treatment or follow-up 2) tretament period 3) treatment period 4) different defined timepoints during treatment and follow-up 5) after surgery | — |
Countries
Germany
Contacts
Public ContactDepartment of Surgery
University Medical Center Regensburg
Outcome results
None listed