Pancreatic neuroendocrine tumours (pan-NETs) are neoplasms arising from the endocrine cells of the pancreas. Although pan-NET are quite rare, the incidence is on the rise and together with other abdominal neuroendocrine tumours an approximate incidence in Sweden would be 850 patients per year extrapolating from Norwegian data. Pan-NET are divided into symptomatic hormone producing tumours (such as insulinomas/glucagonomas/VIPomas) or non-functioning tumours that often are asymptomatic. As early symptoms often are lacking in non-functioning-pan-NET, many patients present with distant metastases and are thus beyond a curative surgical approach at the time of diagnosis. Metastatic non-functioning pan-NETs present a significant challenge and the optimal management remains a subject of debate. This is a prospective, two armed, parallel, randomised, controlled, international multi-centre study, aiming to investigate if a near-total tumour debulking (intervention) in metastatic (stage 4) GI-WHO grade 1-2 pan- NET, with or without oncologic treatment, is superior to oncologic treatment alone (control), with regards to overall survival, health-related quality of life, participant performance status, time until hospitalisation, adverse event characteristics and cost in the short and long term.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
All subjects are divided into STRATUM 1 and STRATUM 2 prior to randomisation. For subjects in STRATUM 1, the surgical resection, alone or in combination with ablative procedures, aim to achieve at least 70% debulking of the total tumour volume, with acceptable risk and acceptable functional liver remnant (FLR). For subjects in STRATUM 2 the aim is to resect or ablate all FluDeoxyGlucose-Positron emission tomography (FDG-PET) avid disease with acceptable risk and acceptable FLR.
Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGSkåne University Hospital
Lund, Sweden
NOT_YET_RECRUITINGKarolinska University Hospital
Stockholm, Sweden
RECRUITINGUppsala University Hospital
Uppsala, Sweden
RECRUITINGOverall survival
Time from randomisation to death.
Time frame: Five years or until death.
Health economics
Estimation of total health economic costs for hospitalisation, ICU stay, and treatments given for the pan-NET disease in each group during follow-up.
Time frame: Until end of trial.
Health-related quality of life
Data on health-related quality of life will be gathered with the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The questionnaire is designed to measure cancer subjects' physical, psychological and social functions. It is composed of multi-item scales and single items.
Time frame: The questionnaire will be filled in by the study subject before randomisation, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Performance status
Performance status is measured using the Karnofsky performance status scale The scale ranges from 100 to 0, with higher scores indicating better functional status.
Time frame: Assessed at screening, at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Days out of hospital
Total number of days alive outside hospital.
Time frame: Assessed at 3 months (+/2weeks), 6 months, and at 1, 2, 3, 4 and 5 years (+/4weeks) after randomisation.
Days out of intensive care unit
Total number of days alive outside intensive care unit.
Time frame: Assessed at 1 and 5 years.
Adverse events
Severe, life threatening and fatal adverse events possibly or probably related to pan-NET treatment during follow-up.
Time frame: From randomisation until the end of the study period.
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