Last updated on February 2019

Perioperative Systemic Therapy and Surgery Versus Surgery Alone for Resectable Colorectal Peritoneal Metastases.


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Peritoneal Cavity Cancer | Peritoneal Metastases | Colorectal Cancer | Peritoneal Neoplasm | Peritoneal Carcinoma | Colorectal Cancer Metastatic | Peritoneal Carcinomatosis | Colorectal Adenocarcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

In order to be eligible to participate in this study, a patient must meet all of the following criteria:

  • PCI score 20 and CC-0 or CC-1 achievable, determined by adequate preoperative work-up;
  • Histological confirmation of non-appendiceal colorectal cancer with non-signet histology in peritoneal deposits or ascites;
  • 18 years or older;
  • WHO performance score 0-1;
  • Adequate clinical condition to undergo cytoreductive surgery with HIPEC and/or neoadjuvant combination chemotherapy with bevacizumab within 4 weeks after randomisation;
  • Adequate organ functions: normal bone marrow function (Hb 6.0 mmol/L, absolute neutrophil count 1.5 x 109/L, platelet count 100 x 109/L), renal function (serum creatinine 1.5 x ULN and creatinine clearance [Cockroft formula] 30 ml/min), determined <3 months prior to randomisation;
  • No known bleeding diathesis or coagulopathy;
  • Written informed consent;
  • Able and willing to adhere to follow-up;

Patients who meet any of the following criteria are excluded from participation in this

study
  • Signet ring cell histology (>50% of the cells have signet ring cell histology) of the primary tumour;
  • Systemic metastases (i.e. liver, lung);
  • Known pregnancy or lactation, wish for pregnancy, and not willing to use contraceptives;
  • Known unstable or uncompensated respiratory or cardiac disease;
  • Serious active infections;
  • Adjuvant chemotherapy after primary resection of colorectal cancer within 6 months prior to randomisation;
  • Any condition not allowing the safe administration of the planned systemic treatment (bevacizumab, 5-fluorouracil, leucovorin, capecitabine, oxaliplatin, irinotecan);
  • Stomatitis, ulceration in the mouth or gastrointestinal tract;
  • Severe diarrhoea;
  • Known pernicious anaemia or other anaemias due to vitamin B12 deficiency;
  • Known previous peripheral sensory neuropathy with functional impairment after previous use of oxaliplatin;
  • Impaired liver function (serum bilirubin 2 x ULN, serum transaminases 5 x ULN), assessment only if indicated.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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