Actively Recruiting
Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs
Led by IRCCS San Raffaele · Updated on 2026-01-15
450
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated.
CONDITIONS
Official Title
Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of well-differentiated GEP-NENs that are localized but not suitable for surgery or are advanced with local or distant metastasis
- Availability of data on the primary tumor site, stage, and date of diagnosis
- Treated with at least one of the following therapies for at least 6 months: somatostatin analogs (for G1 or G2 with Ki67 <10%, as first-line or second-line after surgery), sunitinib or everolimus (for G1/G2, as first- or second-line therapy), or capecitabine-temozolomide (for G2 or G3 with Ki67 <55%, as first-, second-, or third-line therapy)
You will not qualify if you...
- Age under 18 years
- Concurrent treatment with loco-regional therapies
- Previous treatment with radioligand therapy
- Need for capecitabine-temozolomide dose reduction greater than 33% for at least three administrations
- Neuroendocrine neoplasms of unknown primary origin
- Diagnosis of mixed neuroendocrine neoplasms (MiNENs)
- Poorly differentiated neuroendocrine carcinoma
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS OSpedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
M
Matteo Tacelli, PhD
CONTACT
L
Laura Apadula, MSN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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