|- candidate number||28357|
|- NTR Number||NTR6917|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-dec-2017|
|- Secondary IDs||NL59706.078.17 Toetsingonline|
|- Public Title||Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases. |
|- Scientific Title||Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study|
|- hypothesis||HAIP chemotherapy after resection of colorectal liver metastases (CRLM) will be feasible and safe. |
|- Healt Condition(s) or Problem(s) studied||Adjuvant treatment, Hepatic Arterial Infusion Pump (HAIP) chemotherapy, Resectable colorectal liver metastases|
|- Inclusion criteria||• Age ≥ 18 years |
• ECOG performance status 0 or 1
• Clinical Risk Score (CRS) of 0-5
• Histologically confirmed colorectal cancer (CRC)
• Radiologically confirmed and resectable CRLM.
• Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT with excellent arterial phase. The default site for the catheter insertion is the gastroduodenal artery (GDA).
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 15 days prior to inclusion:
o absolute neutrophil count ≥1.5 x 109/L
o platelets ≥100 x 109/L
o HB ≥ 5.5 mmol/L
o Total bilirubin ≤ 1.5 UNL
o ASAT ≤ 5 x UNL
o ALAT ≤ 5 x UNL
o alkaline phosphatase ≤ 5 x UNL
o (calculated) glomerular filtration rate >30 ml/min.
• Written informed consent must be given according to ICH/GCP, and national/local regulations.
|- 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 too small to characterize 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.
• CRLM requiring two-staged liver resections
• (Partial) portal vein thrombosis
• Pregnant 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||2-nov-2017|
|- planned closingdate||2-jul-2018|
|- Target number of participants||10|
|- Interventions||Adjuvant HAIP chemotherapy|
|- Primary outcome||The primary outcome for feasibility is the percentage of successful administration of at least one cycle of HAIP chemotherapy.
|- Secondary outcome||Secondary outcome are treatment related adverse events grade III or higher (chemotherapy related CTCAE, grade III or higher) until 4 weeks after the end of treatment and the accuracy of CT angiography to detect extrahepatic perfusion.|
|- Timepoints||1 month after inclusion of the last patient|
|- Trial web site||www.chemopomp.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| F.E.Buisman|
|- CONTACT for SCIENTIFIC QUERIES|| F.E.Buisman|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Dutch Cancer Society|
|- Publications||N.A. |
|- Brief summary||This is a multicenter feasibility study to optimize the organization of HAIP chemotherapy in two Dutch centers (Erasmus MC Cancer Institute and Antoni van Leeuwenhoek)|
|- Main changes (audit trail)||Extra website: www.pumptrial.nl|
|- RECORD||18-dec-2017 - 10-jan-2018|