Perioperative Systemic Therapy in Patients Undergoing Surgery With HIPEC for Colon Cancer With Peritoneal Metastases: the CAIRO6 Study.

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 340
• Participant gender: Male

Summary

The purpose of this study is to determine whether cytoreductive surgery and HIPEC, combined with preoperative chemotherapy with targeted therapy and postoperative chemotherapy, results in improved overall survival compared to cytoreductive surgery and HIPEC alone in patients with peritoneal metastases of colorectal cancer.

A survival increase of 15% is expected in the systemic therapy group. Furthermore, neoadjuvant systemic therapy may allow for better patient selection.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborator: Hoffmann-La Roche
• Treatments: Bevacizumab; Capecitabine; Fluorouracil; Leucovorin; Oxaliplatin
• Last Updated: 2016-08-29

Criteria

Inclusion criteria:

• PCI score ≤20 and CC-0 or CC-1 achievable, determined by adequate preoperative work-up.

• Pathological confirmation of 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 CRS + HIPEC and 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.

Exclusion criteria:

• 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.

• Known unstable or uncompensated respiratory or cardiac disease.

• Serious active infections.

• Adjuvant chemotherapy after primary resection of colorectal cancer used 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.

• Known dihydropyrimidine dehydrogenase deficiency, determined by dihydropyrimidine dehydrogenase genotyping.