Assessment of combination chemotherapy in colorectal cancer patients with peritoneal metastases by analysing obtained tumor tissue samples (CARCINOSIS). Beurteilung der Effizienz der Kombination...

Mise à jour : Il y a 5 ans
Référence : EUCTR2015-002917-30

Assessment of combination chemotherapy in colorectal cancer patients with peritoneal metastases by analysing obtained tumor tissue samples (CARCINOSIS). Beurteilung der Effizienz der Kombinations-Chemotherapie bei Dick- bzw. Mastdarmkrebspatienten mit Bauchfellmetastasen anhand entommener Tumorgewebeproben (CARCINOSIS)

Femme et Homme

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Extrait

The primary objective of the study is to prospectively assess the histopathological response to neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab in peritoneal tumor deposits of 30 patients with pcCRC by determining the % of viable tumor cells (vtc) in the resected specimen after neoadjuvant chemotherapy using standard pathology. In case of multiple specimens, the median % of viable cells will be calculated and used for analysis. The timepoint of the assessment of the primary objective will be during re-exploratory surgery/surgical cytoreduction between days 78 and 106 of the treatment phase of the study. We hypothesize that there will be >30% responders after neoadjuvant FOLFOXIRI + bevacizumab treatment. Responders will be defined as patients with pCR (0% vtc) and major response (1-49% vtc) after FOLFOXIRI + bevacizumab chemotherapy. Non-responders will be defined as patients with minor/no response (≥50% vtc) after FOLFOXIRI + bevacizumab chemotherapy.


Critère d'inclusion

  • Patients with peritoneal carcinomatosis from colorectal cancer are treated with a combination chemotherapy (FOLFOXIRI+ Bevacizumab)

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