Adjuvant Trial in Pancreatic Neuroendocrine Tumors
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
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.
Eligibility criteria
Qualifiers
Pathologically proven well differentiated neuro-endocrine tumour of the pancreas by local teams
Availability of the primary tumor specimen, allowing accurate WHO classification and determination of MGMT status
Stage I-III based ENETS-UICC 8th classification
Early postoperative context (≤ 4 months)
Disqualifiers
Poorly differentiated tumours (NEC)
Mixed NeuroEndocrine Non NeuroEndocrine tumors (MiNEN)
Neoadjuvant treatment or treatment with chemotherapy regimen used for another malignancy
Pregnant women or breastfeeding women
Trial design
Treatments tested in this trial
- Adjuvant chemotherapy with Capecitabine-Temozolomide
- Active surveillance
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov