Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with recurrent colorectal liver metastases without a history of extrahepatic disease - a phase II study
- Conditions
- recurrence of Colorectal liver metastasesrecurrence of metastases in the liver of colorectal cancer1001981510019818
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Adults with recurrent resectable CRLM without a history of EHD.
• Age >= 18 years.
• ECOG performance status 0 or 1.
• Histologically confirmed colorectal cancer (CRC).
• Liver only recurrence after previous resection of index CRLM
• 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). Accessory or aberrant hepatic
arteries are no contraindication for catheter placement. The GDA should have at
least one branch to the liver remnant; accessory or aberrant hepatic arteries
should be ligated to allow for cross perfusion to the entire liver through
intrahepatic shunts.
• 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 (ANC) >=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 (GFR) >30 ml/min.
• Written informed consent must be given according to ICH/GCP, and
national/local regulations.
• A positive history of extrahepatic disease (including positive portal lymph
nodes) at 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..
• CRLM requiring two-staged liver resections
• recurrent CRLM at same location as previously resected/ablated CRLM and <6
months after its resection.
• Known DPYD-deficiency.
• 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).
• Inclusion in another interventional clinical study with survival as primary
outcome.
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is hepatic progression free survival (hPFS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival , safety (complications) and Progression free survival, </p><br>