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Peritoneal MetastasesPhase 1NCT05056389

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

A Phase 1 study testing Oxaliplatin in people with Peritoneal Metastases and Colo-rectal Cancer, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peritoneal Metastases, Colo-rectal Cancer
What is being tested?
Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNorway
Study dates
17 Sep 2021to 30 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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 for the course of the study through 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. In case of female partner of child-bearing potential, the female partner should use 1 highly effective contraception method as defined in section 5.1.5 - "Other considerations".

Who cannot join

  • Has a history of hypersensitivity to oxaliplatin or to any of the excipients listed in the 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 the patient from meeting the trial requirements
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  • 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 cardiac arrhythmia
  • 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 the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Trial locations and contacts

1 site in 1 country.

Mariusz Goscinski, MD.PhD. contact

004793497857

mariuszg@online.no

Vegar Dagenborg, MD,PhD. contact

vegdag@ous-hf.no

Norway1 site, 1 recruiting

  • The Norwegian, Radium Hospital, Oslo University Hospital

    Oslo, 0379

    Mariusz Goscinski, MD, PhD, 004793497857, mariuszg@online.no

    Vegar Dagenborg, MD, PhD, vegdag@ous-hf.no

    Recruiting

Other trials in Norway

About this study

Official title: Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer - Feasibility Study (NIPEC-OXA)

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.

Read the detailed 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

Being tested
Oxaliplatin
Keywords
NIPEC-LT, Oxaliplatin, CRS, HIPEC
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Intraperitoneal catheter

    Administration of oxaliplatin intraperitoneally

Study groups in NCT05056389
Study groupRoleWhat they receive
NIPEX-OXA armExperimental20 patients treated with NIPEC-OXA after CRS and HIPEC.
Receives: Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Common Terminology Criteria for Adverse Events v. 5

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

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

    Clavien-Dindo classification

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

Secondary outcomes (1)

  1. Number of Participants with Optimal, Suboptimal and Missing Fluid Distribution in the Abdomen Injected Through 2 I.P. Catheters

    CT scans with intraperitoneal contrast

    Measured: 7-14 days after CRS and HIPEC and before the 4th NIPEC-OXA course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2021
  2. Study start17 Sep 2021
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study with 20 eligible patients with peritoneal metastases from colorectal cancer
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05056389
Sponsor's protocol ID
202644
Status last verified
Sep 2021
First submitted
9 Sep 2021
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The sponsor's representatives (e.g. monitors, auditors) and/or regulatory authorities will be allowed access to source data for source data verification in which case a review of those parts of the hospital records relevant to the study may be required.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxaliplatin in people with Peritoneal Metastases and Colo-rectal Cancer, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mariusz Goscinski, MD.PhD. (004793497857, mariuszg@online.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events after Intraperitoneal Chemotherapy Administration (NIPEC-OXA) (time frame: Throughout the entire treatment period, including a 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05056389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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