Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer (NIPEC-OXA)

Inclusion Criteria:

• Age 18 - 75 years
• Able to provide written, informed consent regarding expected cooperation duringtreatment and follow-up according to ICH GCP, and national/local regulations
• Histologically verified CRC
• Histologically verified and/or radiologically/clinically suspected PM from CRC
• Synchronous or metachronous PM from CRS
• If neoadjuvant oxaliplatin-containing chemotherapy is administrated, patientswith absence of progressive disease (assessed by CT)
• In metachronous cases: if adjuvant oxaliplatin-containing chemotherapy, theinterval between oxaliplatin- containing adjuvant chemotherapy and diagnosis ofPM must be >6 months
• Intraperitoneal tumour burden amenable to CRC and HIPEC with Peritoneal Cancer Index (PCI40) ≤ 20, assessed at the time of surgery
• Absence of other metastatic sites, i.e. liver, lungs, central lymph nodes
• Completeness of Cytoreduction (CC) score of 0 is required
• Eastern Cooperative Oncology Group (ECOG) Performance Status either 0 or 141
• Women of childbearing potential (WOCBP), defined as all women physiologically capableof becoming pregnant, should have a negative urine- or serum pregnancy test within 72hours prior to receiving the 1st dose of study medication. If the urine test ispositive or cannot be confirmed as negative, a serum pregnancy test will be required.
• WOCBP should be willing to use 1 highly effective method of birth control or besurgically sterile, or abstain from heterosexual activity for the course of the studythrough 120 days after the last dose of study medication.
• Men in a sexual relationship with a WOCBP must agree to use a condom starting with the 1st dose of study therapy through 120 days after the last dose of study therapy. Incase of female partner of child-bearing potential, the female partner should use 1highly effective contraception method as defined in section 5.1.5 - "Otherconsiderations".

Exclusion Criteria:

• Has a history of hypersensitivity to oxaliplatin or to any of the excipients listed inthe SmPC section 6.1
• Has myelosuppression before starting treatment, ie number of neutrophils granulocytes <1.0 x 109/l and/or number of platelets <75 x 109/l
• Has peripheral sensitive neuropathy with functional outcomes before starting treatment
• Has severe renal impairment (creatinine clearance < 30 ml min) (see the SmPC section 5.2).
• Concurrent or previous diagnosis of invasive cancer within 5 years
• Psychiatric or addictive disorder or other medical condition that would preclude thepatient from meeting the trial requirements
• Participation in another cancer clinical trial
• Patients who, according to current guidelines will be offered i.v. adjuvant therapy
• Significant cardiac or other medical illness that would limit activity or survival,such as severe congestive heart failure, unstable angina, or serious cardiacarrhythmia
• Alcohol or drug abuse
• Any reason why, in the opinion of the investigator, the patient should not participate
• Has a known history of Human Immunodeficiency Virus (HIV)
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
• Is pregnant or breastfeeding, or expecting to conceive or father children within theproject duration of the trial, starting with the screening visit through 120 daysafter the last dose of trial treatment.