NCT04790708

Brief Summary

The rationale behind the purpose of this study lays on:

  • the evidence that PRRT could represent a valuable treatment for the majority of patients with neuroendocrine tumor (NET) in disease progression, operated or inoperable, presenting lesions expressing somatostatin receptors and for which standard treatments are not already available;
  • the current impossibility of acquiring on the market radiolabelled analogues of somatostatin used for PRRT with marketing authorisation;
  • the need to collect a larger case history than in previous studies;
  • the need to stratify the various histotypes based on the response obtained;
  • the need to define new treatment schemes that guarantee the maximum efficacy and the lowest possible toxicity - with low cumulative (and per cycle) activities radiopharmaceutical and according to the concept of dose hyperfractionation - with a view to an optimal balance between risk and benefit.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

March 2, 2021

Last Update Submit

March 5, 2021

Conditions

Neuroendocrine TumorsPeptide Receptor Radionuclide Therapy (PRRT)

Keywords

Neuroendocrine Tumors90Y177LuPRRT

Outcome Measures

Primary Outcomes (1)

  • Disease Control Rate

    Post-treatment evaluation will be performed with: * a clinical examination; * a comparative morphological re-evaluation, using version 1.1 of Response evaluation criteria in solid tumors (RECIST criteria) on Computed Tomography (CT); * a comparative functional re-evaluation, performed both on 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) positron emission computed tomography (PET/CT) and Gallium-68 (68Ga)-DOTATOC PET/CT using visual and semi-quantitative parameters (such as SUVmax). Based on all these parameters, Disease Control Rate will be labelled as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression Disease (PD).

    12 months

Secondary Outcomes (4)

  • Progression Free Survival

    6 months

  • Overall Survival

    6 months

  • Evaluation of PRRT Safety

    6 months

  • Evaluation of Quality of Life

    6 months

Study Arms (6)

Midgut NETs

EXPERIMENTAL

75 patients affected by non-functional and functional NETs arising from: stomach, duodenum, jejunum, ileum, colon and rectum.

Radiation: Lutetium-177 (177Lu)-DOTATOCRadiation: Yttrium-90 (90Y)-DOTATOCRadiation: 177Lu-DOTATOC + 90Y-DOTATOCRadiation: Re-treatment 177Lu-DOTATOCRadiation: Re-treatment 90Y-DOTATOC

Pancreatic NETs

EXPERIMENTAL

75 patients affected by non-functional and functional NETs arising from Pancreas.

Radiation: Lutetium-177 (177Lu)-DOTATOCRadiation: Yttrium-90 (90Y)-DOTATOCRadiation: 177Lu-DOTATOC + 90Y-DOTATOCRadiation: Re-treatment 177Lu-DOTATOCRadiation: Re-treatment 90Y-DOTATOC

Bronchial NETs

EXPERIMENTAL

25 patients affected by non-functional and functional Bronchial NETs.

Radiation: Lutetium-177 (177Lu)-DOTATOCRadiation: Yttrium-90 (90Y)-DOTATOCRadiation: 177Lu-DOTATOC + 90Y-DOTATOCRadiation: Re-treatment 177Lu-DOTATOCRadiation: Re-treatment 90Y-DOTATOC

Sympathetic-Adrenergic axis NEts

EXPERIMENTAL

25 patients affected by non-functional and functional: Pheochromocytoma, Paraganglioma and Neuroblastoma

Radiation: Lutetium-177 (177Lu)-DOTATOCRadiation: Yttrium-90 (90Y)-DOTATOCRadiation: 177Lu-DOTATOC + 90Y-DOTATOCRadiation: Re-treatment 177Lu-DOTATOCRadiation: Re-treatment 90Y-DOTATOC

Other Nets

EXPERIMENTAL

25 patients affected by non-functional and functional NETs arising from Skin, Thyroid (medullary thyroid and anaplastic cancer) and Parathyroids.

Radiation: Lutetium-177 (177Lu)-DOTATOCRadiation: Yttrium-90 (90Y)-DOTATOCRadiation: 177Lu-DOTATOC + 90Y-DOTATOCRadiation: Re-treatment 177Lu-DOTATOCRadiation: Re-treatment 90Y-DOTATOC

Cancers of Unknown Primary Origin (CUP) NETs

EXPERIMENTAL

25 patients affected by non-functional and functional unknown primary NETs

Radiation: Lutetium-177 (177Lu)-DOTATOCRadiation: Yttrium-90 (90Y)-DOTATOCRadiation: 177Lu-DOTATOC + 90Y-DOTATOCRadiation: Re-treatment 177Lu-DOTATOCRadiation: Re-treatment 90Y-DOTATOC

Interventions

Lutetium-177 (177Lu)-DOTATOCRADIATION

5 cycles of 3,7 e 5,55 gigabequerel (GBq) of 177Lu-DOTATOC every 8-10 weeks. Cumulative activity: 18,5 e 27,75 GBq

Also known as: "MONO"
Bronchial NETsCancers of Unknown Primary Origin (CUP) NETsMidgut NETsOther NetsPancreatic NETsSympathetic-Adrenergic axis NEts
Yttrium-90 (90Y)-DOTATOCRADIATION

5 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks. Cumulative activity: 9,25 e 13,875 GBq

Bronchial NETsCancers of Unknown Primary Origin (CUP) NETsMidgut NETsOther NetsPancreatic NETsSympathetic-Adrenergic axis NEts
177Lu-DOTATOC + 90Y-DOTATOCRADIATION

3 cycles of 3,7 e 5,55 GBq of 177Lu-DOTATOC alternated with 2 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks. Cumulative activity: 18,5 e 27,75 GBq of 177Lu-DOTATOC and 9,25 e 13,875 GBq of 90Y-DOTATOC

Also known as: "DUO"
Bronchial NETsCancers of Unknown Primary Origin (CUP) NETsMidgut NETsOther NetsPancreatic NETsSympathetic-Adrenergic axis NEts
Re-treatment 177Lu-DOTATOCRADIATION

3 cycles of 3,7 e 5,55 GBq of 177Lu-DOTATOC every 8-10weeks. Cumulative activity: 11,1 e 16,65 GBq of 177Lu-DOTATOC

Bronchial NETsCancers of Unknown Primary Origin (CUP) NETsMidgut NETsOther NetsPancreatic NETsSympathetic-Adrenergic axis NEts
Re-treatment 90Y-DOTATOCRADIATION

3 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks Cumulative activity: 5,55 e 8,325 GBq of 90Y-DOTATOC

Bronchial NETsCancers of Unknown Primary Origin (CUP) NETsMidgut NETsOther NetsPancreatic NETsSympathetic-Adrenergic axis NEts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥18 years, of both sexes, of any ethnicity;
  • \. Cyto-histological and immunohistochemical diagnosis of NET;
  • \. Evaluation of the cell proliferation index by studying Ki-67 and / or E3 ubiquitin-protein ligase (MIB-1).
  • \. Illness measurable according to RECIST 1.1 criteria by imaging conventional (CT with contrast medium or MRI with contrast medium) not earlier than two months with respect to enrollment;
  • \. Elevated expression of somatostatin receptors documented by PET-CT with 68Ga-DOTATOC in the target lesion (s). It is defined as "high expression of somatostatin receptors "a ratio of Maximum standardized uptake value (SUVmax) lesion / Mean standardized uptake value (SUVmean) muscle ≥ 4: 1 calculated with semi-quantitative analysis on examination PET-CT with 68Ga-DOTATOC;
  • \. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrollment;
  • \. Evaluation of glucose metabolism in the target lesion (s) by PET-CT with 18F-FDG;
  • \. Preserved haematological, hepatic and renal parameters, in particular: white blood cells ≥2500 / μL; platelets ≥ 90000 / μL; hemoglobin ≥ 9 gr / dL; creatinine ≤ 2 mg / dL; bilirubin ≤ 2.5 mg / dL
  • \. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  • \. Life expectancy ≥ 6 months;
  • \. Stable or progressive disease, at any stage, both in operated patients that inoperable;
  • \. Absence of standard treatments already documented and of equal effectiveness;
  • \. Absence of surgical, chemotherapy and / or radiotherapy treatments for at least 30 days. On the other hand, patients in therapy with somatostatin analogues or biologics, such as mechanistic target of rapamycin (m-TOR) inhibitors;
  • \. Voluntary participation in the study by signing the consent form informed, after reading and complete understanding of the information notes.

You may not qualify if:

  • \. Lack of the requirements listed above;
  • \. State of pregnancy;
  • \. Breastfeeding and relative refusal to suspend breastfeeding;
  • \. Participation in another therapeutic experimental clinical protocol in the four weeks prior to the PRRT;
  • \. Bone marrow invasion of disease\> 25% confirmed;
  • \. Previous extensive radiotherapy treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ferrara

Ferrara, 44124, Italy

RECRUITING

Related Publications (91)

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MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Lutetium-177177Lu-octreotide, DOTA(0)-Tyr(3)-Yttrium-9090Y-octreotide, DOTA-Tyr(3)-

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Central Study Contacts

Mirco Bartolomei, MD

CONTACT

0532236082m.bartolomei@ospfe.it

Licia Uccelli, PhD

CONTACT

0532237462licia.uccelli@unife.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director of Nuclear Medicine Unit

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 10, 2021

Study Start

July 2, 2018

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Locations

IT(1)