Regional chemotherapy combined with systemic chemotherapy (PUMP-IT) for potentially resectable colorectal liver metastases

Phase 1

Active, not recruiting

• Conditions: Patients with potentially resectable CRLM without extrahepatic metastases with an indication for systemic therapy as induction or neoadjuvant therapy. Patients have an indication for laparotomy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003260-44-NL
• Lead Sponsor: Stichting Het Nederlands Kanker Instituut-Antoni van leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-08
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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.
oHb = 5.5 mmol/L
oAbsolute neutrophil count (ANC) =1.5 * 109/L
oPlatelets =100 * 109/L
oTotal bilirubin < 1.5 mg/dL
oASAT = 5 * times the upper limit of normal (ULN)
oALAT = 5 * ULN
oAlkaline 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

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 clear-ly 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.

Study & Design

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