E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with resectable colorectal liver metastases |
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E.1.1.1 | Medical condition in easily understood language |
Patients with resectable metastases of colorectal cancer in the liver |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
The first objective of this study is to evaluate the safety and feasibility of adjuvant HAIP chemotherapy after resection of CLM in 2 centres in the Netherlands. |
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E.2.2 | Secondary objectives of the trial |
The second objective is to determine whether CT angiography can replace a nuclear medicine scan to rule out extrahepatic perfusion of the pump. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥ 18 years.
• ECOG performance status 0 or 1
• Clinical Risk Score (CRS) of 0-2, and by discretion of the principal investigator
• Histologically confirmed colorectal cancer (CRC)
• Radiologically confirmed and resectable CLM
• Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT or MRI with adequate arterial phase.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 15 days prior to inclusion:
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E.4 | Principal exclusion criteria |
• Presence of extrahepatic disease (including positive portal lymph nodes) at the time of liver resection or any time since CRC diagnosis. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
• Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously without evidence of recurrence.
• Prior hepatic radiation or resection.
• Two-staged liver resections
• Pregnant women or lactating women.
• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
• Organ allografts requiring immunosuppressive therapy.
• Serious, non-healing wound, ulcer, or bone fracture.
• Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent excluding inhaled steroids).
• Serious infections (uncontrolled or requiring treatment).
• Current or recent (within the 28 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome for safety is the percentage of 90-day postoperative complications (Clavien-Dindo classification, grade III or higher). The primary outcome for feasibility is the percentage of successful administration of at least one cycle of HAIP chemotherapy. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
90 days after surgery of the last patient |
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E.5.2 | Secondary end point(s) |
Secondary outcome are treatment related adverse events grade III or higher (chemotherapy related CTCAE, grade III or higher; appendix D) until 4 weeks after the end of treatment and the accuracy of CT angiography to detect extrahepatic perfusion. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 weeks after end of treatment of the last included patient |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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After administration of the third cycle in the last patient |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |