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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical group | Experimental | Debulking surgery followed by oncologic treatment according to standard routine. Further debulking surgery or ablation may be continued during follow-up to reduce tumour load. |
|
| Non-surgical group | No Intervention | Oncologic treatment alone. No surgical or thermal ablative treatments will be planned after randomisation. Any surgical or ablative procedure for pan-NET that is performed after randomisation in the Non-surgical group is considered as a protocol deviation. However, such procedures may be carried out if clinically indicated and no other equivalent or better oncological options for treatment are available. The surgery is then documented as oncological treatment in eCRF and the subject will continue follow-up in the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debulking surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from randomisation to death. | Five years or until death. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until end of trial. |
| Health-related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olov Norlén, Professor and Consultant, MD, PhD | Contact | +46 18 611 00 00 | olov.norlen@uu.se | |
| Carina Alvfors, Project Manager | Contact | +46 18 611 00 00 | Carina.Alvfors@ucr.uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Olov Norlén, MD, PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D065426 | Cytoreduction Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Prospective, two armed, parallel, randomised, controlled, international multi-centre study
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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.
| 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. | 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. | 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. | 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. | From randomisation until the end of the study period. |
| Skåne University Hospital | Not yet recruiting | Lund | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
|
| Uppsala University Hospital | Recruiting | Uppsala | Sweden |
|
| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |