Spots Global Cancer Trial Database for CapTemY90 for Grade 2 NET Liver Metastases

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Trial Identification

Brief Title: CapTemY90 for Grade 2 NET Liver Metastases

Official Title: UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors

Study ID: NCT04339036

Conditions

Neuroendocrine Tumor Grade 2

Neuroendocrine Tumors

Interventions

Capecitabine Oral Product

Temozolomide Oral Product

transarterial radioembolization

Study Description

Brief Summary: This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.

Detailed Description: Patients with liver-dominant Grade 2 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance. Primary outcome measure is hepatic progression-free survival.