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

NCT05056389 | Unknown Phase 1 DMC

• 1 other identifier: 202644
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Metastases; Colo-rectal Cancer

Keywords

NIPEC-LT; Oxaliplatin; CRS; HIPEC

Outcome Measures

Primary Outcomes (2)

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

  Common Terminology Criteria for Adverse Events v. 5

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

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

  Clavien-Dindo classification

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

Secondary Outcomes (1)

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

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

Study Arms (1)

NIPEX-OXA arm

EXPERIMENTAL

20 patients treated with NIPEC-OXA after CRS and HIPEC.

Drug: Oxaliplatin

Interventions

Oxaliplatin DRUG

Administration of oxaliplatin intraperitoneally

Also known as: Intraperitoneal catheter

NIPEX-OXA arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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".

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The Norwegian, Radium Hospital, Oslo University Hospital

Oslo, 0379, Norway

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Mariusz Goscinski, MD.PhD.

  Oslo University Hospital, The Norwegian Radium Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariusz Goscinski, MD.PhD.

CONTACT

004793497857; mariuszg@online.no

Vegar Dagenborg, MD,PhD.

CONTACT

vegdag@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study with 20 eligible patients with peritoneal metastases from colorectal cancer

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 24, 2021
• Study Start: September 17, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data of the study will be kept 15 years after the end of the study according Norwegian law.
• Access Criteria: Access to the data has to be approved by the PI.

Locations

NO (1)