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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513726-33-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Koningin Wilhelmina Fonds | OTHER |
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The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy) | Experimental | Surgery + chemo pump |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic Arterial Infusion Pump chemotherapy with floxuridin | Combination Product | Participants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Two-year hepatic recurrence free survival (hRFS) | The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples. | From pump implantation until 2 years after that surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall recurrence free survival (RFS) | The percentage of patients who do not have return of disease in the given time frame. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples. | From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bas Groot Koerkamp, MD, PhD | Contact | +31(0)107031810 | b.grootkoerkamp@erasmusmc.nl | |
| Thomas C Zwaan, MD | Contact | +31(0)621218051 | t.zwaan@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Bas Groot Koerkamp, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.
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| Overall survival (OS) | OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up | From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion) |
| Post-operative complications | All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery. | From pump implantation until 90 days after surgery |
| Chemotherapy related adverse events (AEs) | Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0 | From inclusion until 4 weeks after the end of treatment with chemotherapy |
| Proportion of patients started with HAIP chemotherapy | The number of patients that could receive at least 1 cycle of HAIP chemotherapy with floxuridin | From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump |
| Quality of life: EORTC QLQ-30 | After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This validated instrument includes 30 items covering functional domains, symptom scales, and global health status. Scores range from 0 to 100, with higher scores on the global health and functional scales indicating better quality of life. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years. | From inclusion until 5 years after surgery |
| Quality of life: EQ-5D | After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the EuroQol 5-Dimension (EQ-5D) questionnaire, a standardized measure of health-related quality of life. The EQ-5D includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The resulting health state is converted into an index score ranging from 0 (equivalent to death) to 1 (perfect health), though negative scores are possible. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years. | From inclusion until 5 years after surgery |
| Cost-effectiveness | An assessment of the cost-effectiveness of HAIP chemotherapy for patients with iCCA will be made | From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome) |
| Predictive biomarkers in the blood for efficacy of HAIP chemotherapy | A total of five additional blood samples will be collected. These samples will be collected:
| From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first) |
| Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy | Additionally, tumor tissue will be collected from the removed part of the liver during the surgery. These tissue samples will be stored for further research into biomarkers. | From resection until 25 years after (conform applicable laws) |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| C562580 | Cirrhosis, Familial, with Pulmonary Hypertension |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005467 | Floxuridine |
| ID | Term |
|---|---|
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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