Examining factors affecting treatment response in gastroenteropancreatic neuroendocrine tumors

Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs

This study looks at how different factors related to tumors and patients affect how well treatments work for people with gastroenteropancreatic neuroendocrine tumors.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS San Raffaele (other)
• Drugs / interventions: Sunitinib, chemotherapy
• Locations: 1 site (Milan)
• Trial ID: NCT06356467 on ClinicalTrials.gov

What this trial studies

This observational study investigates how various tumor and patient-related factors influence the response to medical treatments in patients with well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). It involves a retrospective analysis of data collected from multiple centers, focusing on progression-free survival as the primary outcome. Additionally, a subgroup of patients will undergo transcriptome analysis to identify potential biomarkers that may predict treatment responses. The study aims to clarify the relationship between clinical variables and tumor behavior under treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with well-differentiated, localized or advanced GEP-NENs who have received specific medical therapies for at least six months.

Not a fit: Patients under 18, those treated with loco-regional therapies, or those previously receiving radioligand therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with GEP-NENs, improving their outcomes.

How similar studies have performed: While the study's approach is observational and builds on existing knowledge, similar studies have shown promise in understanding treatment responses in neuroendocrine tumors.

Eligibility criteria

Inclusion Criteria:

* Age \>= 18
* Well-differentiated, localized (but not suitable for surgical treatment) or advanced (locally or with distant metastasis) GEP-NENs
* availability of data on site of primary tumor, stage of the, date of diagnosis
* treated with one (or more) of the following therapies:

  * Somatostatin analogs

    * G1 or G2 (Ki67 \<10%) GEP-NENs
    * Treated for at least 6 months
    * first-line therapy (or as second-line after surgery in patients with residual disease or recurrence after surgical resection)
  * Sunitinib/Everolimus

    * G1/G2 GEP-NENs
    * Treated for at least 6 months
    * first- or second-line therapy
  * Capecitabine-Temozolomide (CAP-TEM)

    * G2 or G3 (Ki67 \< 55%) GEP-NENs
    * first-, second-, or third-line therapy
    * Treated for at least 6 months

Exclusion Criteria:

* Age \< 18aa
* Patients concomitantly treated with loco-regional treatments
* Patients previously treated with radioligand therapy
* Patients with need of CAP-TEM dose reduction of more than 33% for at least 3 administrations
* NENs of unknown primitivity (including patients with biopsy on secondary lesion compatible with metastasis from GEP-NEN, but with occult primary neoplasm)
* Patients with Mixed NENs (MiNENs)
* Patients with poorly differentiated neuroendocrine carcinoma
* Pregnancy and breastfeeding

Where this trial is running

Milan

• IRCCS OSpedale San Raffaele — Milan, Italy (RECRUITING)

Study contacts

• Principal investigator: Gabriele Capurso, PhD — IRCCS Ospedale San Raffaele
• Study coordinator: Matteo Tacelli, PhD

Conditions: Neuroendocrine Tumors, GEP-NET, GEP-NEN, NEN