Description:
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.
Title
- Brief Title: Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)
- Official Title: Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors
Clinical Trial IDs
- ORG STUDY ID:
160990
- SECONDARY ID:
2016-005129-35
- NCT ID:
NCT04790708
Conditions
- Neuroendocrine Tumors
- Peptide Receptor Radionuclide Therapy (PRRT)
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
Midgut NETs | Experimental | 75 patients affected by non-functional and functional NETs arising from: stomach, duodenum, jejunum, ileum, colon and rectum. | |
Pancreatic NETs | Experimental | 75 patients affected by non-functional and functional NETs arising from Pancreas. | |
Bronchial NETs | Experimental | 25 patients affected by non-functional and functional Bronchial NETs. | |
Sympathetic-Adrenergic axis NEts | Experimental | 25 patients affected by non-functional and functional: Pheochromocytoma, Paraganglioma and Neuroblastoma | |
Other Nets | Experimental | 25 patients affected by non-functional and functional NETs arising from Skin, Thyroid (medullary thyroid and anaplastic cancer) and Parathyroids. | |
Cancers of Unknown Primary Origin (CUP) NETs | Experimental | 25 patients affected by non-functional and functional unknown primary NETs | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease Control Rate |
Time Frame: | 12 months |
Safety Issue: | |
Description: | 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). |
Secondary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Overall Survival |
Time Frame: | 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Evaluation of PRRT Safety |
Time Frame: | 6 months |
Safety Issue: | |
Description: | 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. |
Measure: | Evaluation of Quality of Life |
Time Frame: | 6 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University Hospital of Ferrara |
Trial Keywords
- Neuroendocrine Tumors
- 90Y
- 177Lu
- PRRT
Last Updated
March 10, 2021