Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.
18 Years
71 Years
Both
Peritoneal Carcinomatosis, Colorectal Cancer Metastatic
Trial Information
Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.
More than 10% of patients with colorectal cancer (CRC) already show peritoneal
carcinomatosis at the time of initial diagnosis and up to 25% of all patients develop
peritoneal carcinomatosis during the natural course of their disease as a common sign of
tumor progression or recurrence.
The existing data suggests that CRS and HIPEC as an integral part of a multidisciplinary
treatment concept may improve long-term survival of selected patients with peritoneal
carcinomatosis of colonic origin. Moreover, hyperthermic peritoneal perfusion with
oxaliplatin in combination with synchronous application of 5-FU/leucovorin seems to improve
the efficacy of HIPEC in comparison to a mitomycin C-based intraperitoneal treatment regimen
and may lead to a better local tumor control. The improved systemic treatment strategy with
neoadjuvant chemotherapy may lead to increased rates of complete macroscopic cytoreduction
and together with the adjuvant treatment to better control of distant metastasis and tumor
recurrence. However, there is no prospective study available evaluating the clinical and
oncological outcome after standard-of-care chemotherapy including targeted anticancer
therapy in combination with CRS and HIPEC. The published morbidity and mortality rates after
CRS and HIPEC are comparable to other major gastrointestinal surgery and seem to be
acceptable considering the expected improvement of oncological outcome.
Inclusion Criteria:
- Synchronous or metachronous peritoneal carcinomatosis arising from histologically
proven colorectal or appendiceal adenocarcinoma
- Complete macroscopic cytoreduction (CCR-0/1)
- Free treatment interval of at least 6 month after the last chemotherapy
- 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.
Exclusion Criteria:
- Incomplete cytoreduction
- Hematogenous metastasis including irresectable liver metastasis
- Prior chemotherapy or therapy with EGFR receptor antibody for metastatic disease
- K-ras mutation
- Known allergy to murine or chimeric monoclonal antibodies
- Histology of signet ring carcinoma
- Other malignancy than disease under study / second cancer
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS)
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
Pompiliu Piso, Prof. MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Regensburg
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
24/06/2009
NCT ID:
NCT01540344
Start Date:
October 2010
Completion Date:
October 2017
Related Keywords:
- Peritoneal Carcinomatosis
- Colorectal Cancer Metastatic
- peritoneal carcinomatosis
- cytoreductive surgery
- HIPEC
- colorectal cancer
- Colonic Neoplasms
- Colorectal Neoplasms
- Carcinoma
- Neoplasms
- Neoplasms, Second Primary
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