UnknownPhase 1

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

Norway20 participantsStarted 2021-09-17

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 - 75 years * Able to provide written, informed consent regarding expected cooperation during treatment 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, patients with absence of progressive disease (assessed by CT) * In metachronous cases: if adjuvant oxaliplatin-containing chemotherapy, the interval between oxaliplatin- containing adjuvant chemotherapy and diagnosis of PM 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 capable of becoming pregnant, should have a negative urine- or serum pregnancy test within 72 hours prior to receiving the 1st dose of study medication. If the urine test is positive 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 be surgically sterile, or abstain from heterosexual activity f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events after Intraperitoneal Chemotherapy Administration (NIPEC-OXA)

Timeframe: Throughout the entire treatment period, including a 3-month follow-up

Number of Participants with Surgical Complications after CRS, HIPEC and NIPEC-OXA

Timeframe: Throughout the entire treatment period, including a 3-month follow-up

Trial details

NCT IDNCT05056389

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

Contact for this trial

Mariusz Goscinski, MD.PhD.

004793497857 mariuszg@online.no

View on ClinicalTrials.gov More Peritoneal Metastases trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Adverse Events after Intraperitoneal Chemotherapy Administration (NIPEC-OXA)

Timeframe: Throughout the entire treatment period, including a 3-month follow-up

Number of Participants with Surgical Complications after CRS, HIPEC and NIPEC-OXA

Timeframe: Throughout the entire treatment period, including a 3-month follow-up