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van CCT (UK)

van CCT (UK)

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases.

- candidate number28357
- NTR NumberNTR6917
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-dec-2017
- Secondary IDsNL59706.078.17 Toetsingonline
- Public TitleAdjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases.
- Scientific TitleAdjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study
- hypothesisHAIP chemotherapy after resection of colorectal liver metastases (CRLM) will be feasible and safe.
- Healt Condition(s) or Problem(s) studiedAdjuvant 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 2-nov-2017
- planned closingdate2-jul-2018
- Target number of participants10
- InterventionsAdjuvant HAIP chemotherapy
- Primary outcomeThe primary outcome for feasibility is the percentage of successful administration of at least one cycle of HAIP chemotherapy.
- Secondary outcomeSecondary 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.
- Timepoints1 month after inclusion of the last patient
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Rotterdam, Dutch Cancer Society
- PublicationsN.A.
- Brief summaryThis 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:
- RECORD18-dec-2017 - 10-jan-2018

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