drugset / Trial / NCT07591493

Adjuvant Trial in Pancreatic Neuroendocrine Tumors

NCT07591493

Phase 3 Not yet recruiting 300 enrolled Gustave Roussy, Cancer Campus, Grand Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

ADJUPANET is an open label, double arm, multicenter, phase 3 trial that aims to investigate the efficacy of systemic chemotherapy in locally resected aggressive pancreatic neuroendocrine tumors. The two arms of patients are the following : i. control arm : active surveillance only, standard of care. ii. experimental arm : adjuvant chemotherapy with 6 cycles of CAPECITABINE-TEMOZOLOMIDE (per os) and active surveillance. Patients enrolled in the experimental arm will receive Capecitabine CAPECITABINE per os 750 mg/m² (twice a day: D1 to D14) D1=D28 and TEMOZOLOMIDE per os 200 mg/m² (once a day: D10 to D14) D1=D28.

Timeline

Start
2026-09
Primary completion
2035-06
Completion
2035-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral