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Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2) (FENET-2016)

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ClinicalTrials.gov Identifier: NCT04790708
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Mirco Bartolomei, University Hospital of Ferrara

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 10, 2021
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE July 2, 2018
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
Disease Control Rate [ Time Frame: 12 months ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • Progression Free Survival [ Time Frame: 6 months ]
    Progression free survival is defined as the time intercurrent from treatment start to the date of first observation of documented disease progression or death due to any cause.
  • Overall Survival [ Time Frame: 6 months ]
    Overall survival is defined as the time intercurrent from treatment start to the date of death due to any cause, or the date of last contact.
  • Evaluation of PRRT Safety [ Time Frame: 6 months ]
    The evaluation of Treatment-Emergent Adverse Events, defined as any G3/G4 toxicity. The evaluation will be performed during every treatment cycle and after 12, 18, 24, 30, 36 and 42 months after the last treatment cycle and will be based on version 4.0 of Common Terminology Criteria for Adverse Events (CTC-AE) toxicity criteria.
  • Evaluation of Quality of Life [ Time Frame: 6 months ]
    Quality of Life (QoL) will be evaluated with quality of life questionnaire, version 3 (QLQ-C30) by European Organisation for Research and Treatment of Cancer (EORTC). The questionnaire includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)
Official Title  ICMJE Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumors
  • Peptide Receptor Radionuclide Therapy (PRRT)
Intervention  ICMJE
  • Radiation: Lutetium-177 (177Lu)-DOTATOC
    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
    Other Name: "MONO"
  • Radiation: Yttrium-90 (90Y)-DOTATOC
    5 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks. Cumulative activity: 9,25 e 13,875 GBq
  • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC

    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

    Other Name: "DUO"
  • Radiation: Re-treatment 177Lu-DOTATOC
    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
  • Radiation: Re-treatment 90Y-DOTATOC
    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
Study Arms  ICMJE
  • Experimental: Midgut NETs
    75 patients affected by non-functional and functional NETs arising from: stomach, duodenum, jejunum, ileum, colon and rectum.
    Interventions:
    • Radiation: Lutetium-177 (177Lu)-DOTATOC
    • Radiation: Yttrium-90 (90Y)-DOTATOC
    • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC
    • Radiation: Re-treatment 177Lu-DOTATOC
    • Radiation: Re-treatment 90Y-DOTATOC
  • Experimental: Pancreatic NETs
    75 patients affected by non-functional and functional NETs arising from Pancreas.
    Interventions:
    • Radiation: Lutetium-177 (177Lu)-DOTATOC
    • Radiation: Yttrium-90 (90Y)-DOTATOC
    • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC
    • Radiation: Re-treatment 177Lu-DOTATOC
    • Radiation: Re-treatment 90Y-DOTATOC
  • Experimental: Bronchial NETs
    25 patients affected by non-functional and functional Bronchial NETs.
    Interventions:
    • Radiation: Lutetium-177 (177Lu)-DOTATOC
    • Radiation: Yttrium-90 (90Y)-DOTATOC
    • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC
    • Radiation: Re-treatment 177Lu-DOTATOC
    • Radiation: Re-treatment 90Y-DOTATOC
  • Experimental: Sympathetic-Adrenergic axis NEts
    25 patients affected by non-functional and functional: Pheochromocytoma, Paraganglioma and Neuroblastoma
    Interventions:
    • Radiation: Lutetium-177 (177Lu)-DOTATOC
    • Radiation: Yttrium-90 (90Y)-DOTATOC
    • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC
    • Radiation: Re-treatment 177Lu-DOTATOC
    • Radiation: Re-treatment 90Y-DOTATOC
  • Experimental: Other Nets
    25 patients affected by non-functional and functional NETs arising from Skin, Thyroid (medullary thyroid and anaplastic cancer) and Parathyroids.
    Interventions:
    • Radiation: Lutetium-177 (177Lu)-DOTATOC
    • Radiation: Yttrium-90 (90Y)-DOTATOC
    • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC
    • Radiation: Re-treatment 177Lu-DOTATOC
    • Radiation: Re-treatment 90Y-DOTATOC
  • Experimental: Cancers of Unknown Primary Origin (CUP) NETs
    25 patients affected by non-functional and functional unknown primary NETs
    Interventions:
    • Radiation: Lutetium-177 (177Lu)-DOTATOC
    • Radiation: Yttrium-90 (90Y)-DOTATOC
    • Radiation: 177Lu-DOTATOC + 90Y-DOTATOC
    • Radiation: Re-treatment 177Lu-DOTATOC
    • Radiation: Re-treatment 90Y-DOTATOC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2021)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age ≥18 years, of both sexes, of any ethnicity;
  • 2. Cyto-histological and immunohistochemical diagnosis of NET;
  • 3. Evaluation of the cell proliferation index by studying Ki-67 and / or E3 ubiquitin-protein ligase (MIB-1).
  • 4. 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;
  • 5. 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;
  • 6. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrollment;
  • 7. Evaluation of glucose metabolism in the target lesion (s) by PET-CT with 18F-FDG;
  • 8. 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
  • 9. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  • 10. Life expectancy ≥ 6 months;
  • 11. Stable or progressive disease, at any stage, both in operated patients that inoperable;
  • 12. Absence of standard treatments already documented and of equal effectiveness;
  • 13. 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;
  • 14. Voluntary participation in the study by signing the consent form informed, after reading and complete understanding of the information notes.

Exclusion Criteria:

  • 1. Lack of the requirements listed above;
  • 2. State of pregnancy;
  • 3. Breastfeeding and relative refusal to suspend breastfeeding;
  • 4. Participation in another therapeutic experimental clinical protocol in the four weeks prior to the PRRT;
  • 5. Bone marrow invasion of disease> 25% confirmed;
  • 6. Previous extensive radiotherapy treatments.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mirco Bartolomei, MD 0532236082 m.bartolomei@ospfe.it
Contact: Licia Uccelli, PhD 0532237462 licia.uccelli@unife.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04790708
Other Study ID Numbers  ICMJE 160990
2016-005129-35 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Mirco Bartolomei, University Hospital of Ferrara
Study Sponsor  ICMJE University Hospital of Ferrara
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital of Ferrara
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP