E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastases from Colorectal Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Metastases from Colorectal cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Analysis of chemotherapy toxicity given through i.p. during NIPEC-OXA throughout the entire treatment period, including a 3-month follow-up. |
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E.2.2 | Secondary objectives of the trial |
1. Analysis of the 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
2. Surgical complications after CRS, HIPEC and NIPEC-OXA until 3 months after the last NIPEC-OXA course
3. Treatment efficacy assessment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 and/or radiologically verified diagnosis of PM from CRC
•Syncronous PM at CRS surgery with removal of primary tumour
o If neoadjuvant oxaliplatin-containing chemotherapy is administrated, patients with absence of progressive disease (assessed by CT)
o 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 Cytoreductin (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 first 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 one 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. The majority of WOCBP that are exposed to cancer-targeting Investigational Medicinal Products (IMPs) must use highly effective contraception’s as standard time in general 4-6 months after last administration.
•Men in a sexual relationship with a WOCBP must agree to use a condom starting with the first 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 one highly effective contraception method as defined in section 5.1.5 – “Other considerations”. |
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E.4 | Principal exclusion criteria |
•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 intravenous 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse Event meassured by CTCAE 5.0 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the entire treatment period, including a 3-month follow-up. |
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E.5.2 | Secondary end point(s) |
1. Chemotherapy access to abdominal compartments after i.p. drug administration.
2. Adverse Event meassured by Clavien-Dindo classification
3. Overall survival and diseasefree survival |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 7-14 days after CRS and HIPEC and before the 4th NIPEC-OXA course
2. After the CRS, HIPEC and NIPEC-OXA surgery and until 3 months after the last NIPEC-OXA course
3. At course 4 and until 3 months after the last NIPEC-OXA course. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |