A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial
| Autor: | Glockzin, Gabriel, Rochon, Justine, Arnold, Dirk, Lang, Sven A, Klebl, Frank, Zeman, Florian, Koller, Michael, Schlitt, Hans J, Piso, Pompiliu |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Cancer Research
Time Factors Peritoneal Neoplasms/therapy ras Proteins/genetics 610 Medizin Cetuximab Adenocarcinoma Digestive System Surgical Procedures/adverse effects lcsh:RC254-282 Disease-Free Survival Proto-Oncogene Proteins p21(ras) Study Protocol Hypothermia Induced Germany Proto-Oncogene Proteins Antineoplastic Combined Chemotherapy Protocols Genetics Humans Cytoreductive surgery Prospective Studies Digestive System Surgical Procedures Peritoneal Neoplasms ddc:610 Perioperative chemotherapy HIPEC Chemotherapy Cancer Regional Perfusion/adverse effects Appendiceal Neoplasms/therapy Metastasectomy Metastasectomy/adverse effects lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Colorectal cancer Adenocarcinoma/therapy Proto-Oncogene Proteins/genetics Treatment Outcome Oncology Hypothermia Induced/adverse effects Appendiceal Neoplasms Colorectal Neoplasms/therapy Chemotherapy Adjuvant Research Design Chemotherapy Cancer Regional Perfusion Sample Size Quality of Life ras Proteins Feasibility Studies Cytoreductive surgery HIPEC Perioperative chemotherapy Cetuximab Colorectal cancer Peritoneal carcinomatosis Antineoplastic Combined Chemotherapy Protocols/therapeutic use Colorectal Neoplasms Peritoneal carcinomatosis |
| Zdroj: | BMC Cancer BMC Cancer, Vol 13, Iss 1, p 67 (2013) |
| Popis: | Background Peritoneal carcinomatosis is regarded as a common sign of advanced tumor stage, tumor progression or local recurrence of appendiceal and colorectal cancer and is generally associated with poor prognosis. Although survival of patients with advanced stage CRC has markedly improved over the last 20 years with systemic treatment, comprising combination chemotherapy +/− monoclonal antibodies, the oncological outcome—especially of the subgroup of patients with peritoneal metastases—is still unsatisfactory. In addition to systemic therapy, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are specific treatment options for a selected group of these patients and may provide an additional therapeutic benefit in the framework of an interdisciplinary treatment concept. Methods/design The COMBATAC trial is a prospective, multicenter, open-label, single-arm, single-stage phase II trial investigating perioperative systemic polychemotherapy including cetuximab in combination with CRS and HIPEC patients with histologically proven wild-type KRAS colorectal or appendiceal adenocarcinoma and synchronous or metachronous peritoneal carcinomatosis. The planned total number of patients to be recruited is 60. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), perioperative morbidity and treatment-associated toxicity, feasibility of the combined treatment regimen, quality of life (QoL) and histopathological regression after preoperative chemotherapy. Discussion The COMBATAC trial is designed to evaluate the feasibility and efficacy of the combined multidisciplinary treatment regimen consisting of perioperative systemic combination chemotherapy plus cetuximab and CRS plus bidirectional HIPEC with intraperitoneal oxaliplatin. Trial registration ClinicalTrials.gov Identifier: NCT01540344, EudraCT number: 2009-014040-11 |
| Databáze: | OpenAIRE |
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