Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT06356467
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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06356467
Study Brief:
Protocol Section:
NCT06356467