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Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

ConditionNeuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University Hospital

About this trial

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Written informed consent

Eastern Cooperative Oncology Group (ECOG) 0-1

Presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma.

Disqualifiers

Pregnancy or lactation

Previous treatment with PRRT

Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA)

Contraindications for treatment with capecitabine according to the approved label.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 177Lu-DOTATOC

    Drug

    The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor). The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

  • Capecitabine

    Drug

    Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: 177Lu-DOTATOC + CapecitabineExperimental treatment 2 interventions
Group B: 177Lu-DOTATOCExperimental treatment 1 intervention
Group C: Standard 177Lu-DOTATOCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Median progression free survival (PFS) defined as time from randomization to radiological progression.

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.

Time frame
Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks weeks, at follow up (every 3-6 month (investigators choice) until progression.
2

Median progression free survival (PFS) defined as time from randomization to radiological progression.

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 10 +/- 2 weeks.

Time frame
Before start of treatment (within 4 weeks), then every 10 +/- week at follow up (every 3-6 month (investigators choice) until death.
3

Median progression free survival (PFS) defined as time from randomization to radiological progression,

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.

Time frame
Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks, at follow up (every 3-6 month (investigators choice) or patients withdrawal of concent.. No end can be given.

Secondary outcomes

1

Rate of treatment-related adverse reactions

Treatment-related adverse reactions graded according to CTCAE v.5.0.

Time frame
At every treatment cycle, cycle length is 10 +/-2 weeks, at treatment follow up every 3-6 month (investigators choice) until progression. No time point can be given.
2

Median overall survival (OS).

Median OS defined as time from randomization to death of any cause.

Time frame
From date of randomization until the date of death. Timepoint unknown, as date of death can´t be predicted.
3

Progression free survival.

Median progression free survival (PFS).

Time frame
From time of randomization until the date of first documented progression. Is evaluated within 4 weeks before randomization, after each treatment, every 10 +/2 weeks. Timepoint unknown, as date of progression can´t be predicted.
4

Percent change in sum of longest diameters (SLD) of tumor lesions.

Percent change in SLD from baseline (within 4 weeks before treatment) to time of best response.

Time frame
At each radiological investigation with CT or MRI of thorax and abdomen. Is done every 10 +/- 2 weeks. In the follow up period, evaluations are done every 3-6 months until death.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University Hospital

Lead sponsor

Source ClinicalTrials.gov
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