Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pan- NET, ENETS/AJCC stage 4 determined by CT or PET/CT

Primary tumour or metastases confirmed as Pancreatic NET GI-WHO grade 1-2 pan-NET by histology or cytology

Age ≥ 18 years

Written informed consent obtained

Disqualifiers

Subject not fit for surgery due to comorbidity or advanced age (reason to be specified)

Risk of surgery deemed too high by MDT or Surgeon (reason to be specified)

Previous surgery for pan-NET.

Hormonal symptoms caused by a functional pan-NET, not controllable by medical therapy, indicating debulking surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Debulking surgery

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Surgical groupExperimental treatment 1 intervention
Group B: Non-surgical groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Time from randomisation to death.

Time frame
Five years or until death.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

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