Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases

Phase 2

Conditions: colorectal carcinoma
10017991
10019818

Registration Number: NL-OMON55263

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 31

Inclusion Criteria

* Age * 18 years.
* ECOG performance status 0 or 1.
* Life expectancy of at least 12 weeks.
* Histologically confirmed CRC
* Indication for first or second line systemic therapy, confirmed in a
multidisciplinary meeting.
* Potentially resectable (i.e. unresectable and upfront resectable CRLM with
indication for neoadjuvant systemic therapy), confirmed in a multidisciplinary
meeting and radio-logically on (PET) CT thorax/abdomen and/or MRI obtained * 4
weeks prior to regis-tration.
* Positioning of a catheter for HAIP chemotherapy is technically feasible
confirmed in the multidisciplinary liver meeting based on imaging. The default
site for the catheter insertion is the gastroduodenal artery (GDA). Accessory
or aberrant hepatic arteries are no contra-indication for catheter
implantation. The GDA should have at least one branch to the liver, accessory
or aberrant hepatic arteries should be ligated to allow for cross perfusion to
the entire liver through intrahepatic shunts.
* Indication and eligibility for abdominal surgery confirmed in a
multidisciplinary meet-ing, e.g. primary tumour resection, stoma
revision/reversal and diagnostic surgery.
* In case of primary tumour in situ: tumour should be (potentially) resectable,
confirmed in a multidisciplinary meeting.
* Adequate bone marrow, liver and renal function as assessed by the following
laborato-ry requirements to be conducted within 15 days prior to inclusion.
o Hb * 5.5 mmol/L
o Absolute neutrophil count (ANC) *1.5 * 109/L
o Platelets *100 * 109/L
o Total bilirubin < 1.5 mg/dL
o ASAT * 5 * times the upper limit of normal (ULN)
o ALAT * 5 * ULN
o Alkaline phosphatase * 5 * ULN
o (estimated) glomerular filtration rate (eGFR) > 45 ml/min.
* Before patient registration, written informed consent must be given and
signed accord-ing to ICH-GCP, and national/local regulations.

Exclusion Criteria

* Extrahepatic metastases. Confirmed with CT thorax/abdomen obtained * 4 weeks
prior to registration. Patients with small (* 1 cm) extrahepatic lesions that
are not clearly suspicious of metastases are eligible.
* Prior hepatic radiation, resection (other than biopsy), or ablation.
* Concurrent malignancies that interfere with the planned study treatment or
the prog-nosis of CRLM.
* Participation in other clinical trials interfering with the study treatment
as judged by the treating physician.
* Dihydropyrimidine dehydrogenasedeficiency (DPD deficiency).
* Pregnant or lactating women.
* Serious concomitant systemic disorders that would compromise the safety of
the pa-tient 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).
* History of psychiatric disability judged by the investigator to potentially
hamper com-pliance with the study protocol and follow-up schedule.
* Any psychological, familial, sociological or geographical condition
potentially hamper-ing compliance with the study protocol and follow-up
schedule.
* Pregnant or lactating women.
* 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).
* History of psychiatric disability judged by the investigator to potentially
hamper compliance with the study protocol and follow-up schedule.
* Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule.