Adjuvant regional chemotherapy after surgery for colorectal liver metastases - a feasibility study

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Patients with resectable colorectal liver metastases

• Registration Number: EUCTR2016-004299-24-NL
• Lead Sponsor: Erasmus MC Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-09
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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:

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified