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01.Molecular Pathogenesis Of Colorectal Cancer: Implications For Molecular Diagnosis (pp. 1-23)
02.Role Of Phytochemicals In Colon Carcinogenesis (pp. 41-64)
03.Treatment Of Advanced Colorectal Cancer: Current Status And Future Perspectives (pp. 171-208)
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Development And Application Of A New Trial Design For The Analysis Of An Immune Modulator G-Csf (Granulocyte-Colony Stimulating Factor) For Improvement Of Postoperative Outcome In High Risk Colorectal Cancer Patients ...(pp. 241-285) $25.00
Authors:  Bauhofer, A.; Lorenz, W.; Stinner, B.; Torossian, A; Plaul, U.; Koller, M.; Sitter, H.; Celik, I. and Lucerne Group for Consensus assisted(University of Marburg, Germany)
Abstract:
A new trial design for a surgical outcome trial with an immune modulator was developed by consensus of an international study group. Granulocyte-colony stimulating factor (GCSF, filgrastim) was tested in a randomized, controlled trial for prevention of postoperative infectious complications and a sub-optimum recovery from operation in patients with colorectal cancer and increased perioperative risk (ASA 3 and 4). The rationale for the trial and the design of the randomized, placebo controlled, doubleblinded trial (n = 40 patients for each group) is described in this chapter. This prototype trial includes the following elements:
The study population was restricted to patients with high risk (ASA 3 and 4) and left sided surgical resection of colorectal cancer.
Clinic modeling randomized trials (CMRTs) in rodents were used to help to define trial conditions.
Patients were allocated by random to the control or treatment group (n = 40/group). Two antibiotics (A = cefuroxime/metronidazole and B = ofloxacin/metronidazole) were balanced, randomized in a 2 x 2 design (G-CSF/placebo x antibiotic A/B) in the trial. The double blinding strategy of the trial was assessed by psychometric indices.
A new endpoint construct (integrated outcome concept) was evaluated with quality of life (EORTC-QLQ-C30 and QLQ-C38 cancer module) and a recovery index (Mc Peek index) were used as primary endpoints. Qualitative analysis of clinical relevance was performed by both patients and doctors.
A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life at discharge from hospital, two and six months after operation. The second primary endpoint is the McPeek index.
The management of postoperative complications was directed by an evidence based
guideline. A new trial design for preoperative prophylaxis and postoperative recovery was developed and used to avoid previous methodological failures. The trial was performed in three centers within two years plus an additional half year for follow up. At present it can be concluded that the trial protocol is feasible and can therefore be used to test other immune-modulators in complex clinical scenarios. Data analysis will demonstrate the effect of G-CSF on the different endpoints. 


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Development And Application Of A New Trial Design For The Analysis Of An Immune Modulator G-Csf (Granulocyte-Colony Stimulating Factor) For Improvement Of Postoperative Outcome In High Risk Colorectal Cancer Patients ...(pp. 241-285)