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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    20
  • sponsor
    Oslo University Hospital
Updated on 9 October 2021

Summary

Feasibility study regarding 20 Patients with peritoneal metastases from colorectal cancer treated with cytoreductive surgery and HIPEC and subsequently with 4 courses of normothermic intraperitoneal chemotherapy - long term (NIPEC-OXA) with oxaliplatin.

Description

Primary endpoint: to determine if the administration of additional i.p. chemotherapy for a period of 9 weeks after completed CRS and HIPEC is a safe procedure to be used in the future in a formal randomised trial. The toxicity of the chemotherapy given through i.p. during NIPEC-OXA courses will be analysed throughout the entire treatment period and a subsequent 3-month follow-up period.

Secondary endpoints:

  1. Intra-abdominal chemotherapy drug distribution 7-14 days after CRS and HIPEC and before the 4th NIPEC-OXA course
  2. Surgical complications after CRS, HIPEC and NIPEC-OXA until 3 months after the last NIPEC-OXA course
  3. Disease-free survival (DFS)
  4. Overall survival (OS)

Exploratory endpoint: quality of life

Estimated date of first patient enrolled: 3rd quarter of 2021 Anticipated recruitment period: 1,5 years Estimated treatment completion date of last patient: 1st quarter of 2023 Expected treatment duration per patient: 9 weeks Expected follow-up period per patient: 3 months after the last NIPEC-OXA procedure

Details
Condition Colon cancer; rectal cancer, Colon Cancer Screening, Peritoneal Metastases, Colorectal Cancer
Treatment Oxaliplatin
Clinical Study IdentifierNCT05056389
SponsorOslo University Hospital
Last Modified on9 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy
Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form
Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria

Subject concomitantly enrolled or scheduled to be enrolled in another trial
Evolving mild, moderate or severe illness, especially infectious diseases or fever (axilary temperature 37.5C)
Known history of allergy to any component of the vaccines
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppressants)
Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
Pregnancy & lactation (Adults)
Individuals who have previously received any vaccines against typhoid fever
Subjects already vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine
Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time
Subject planning to move from the study area before the end of study period
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