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

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


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.


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

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


Yes No Not Sure

Inclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note