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Adjuvant Trial in Pancreatic Neuroendocrine Tumors

NCT07591493 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Pancreatic Neuroendocrine Tumors (pNET)
  • Pancreatic Neuroendocrine Tumors

Interventions

DRUG

Adjuvant chemotherapy with Capecitabine-Temozolomide

Chemotherapy with Capecitabine-Temozolomide (per os) for 6 cycles (6 months): * CAPECITABINE per os 750 mg/m² (twice a day: D1 to D14) D1=D28 * TEMOZOLOMIDE per os 200 mg/m² (once a day: D10 to D14) D1=D28

OTHER

Active surveillance

Active surveillance according to the European Society for Medical Oncology (ESMO) and French Thesaurus National de Cancérologie Digestive (TNCD) guidelines with every 3 months for 2 years, every 4 months for 1 year and then every 6 months for 2 years: * Evaluation and physical examination of a functional clinical syndrome (hormone- and tumor-related symptoms) * Biological: chromogranin A and/or appropriate hormone biomarker if positive in the preoperative setting * Radiological: thoracic CT and abdomen CT or MRI

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2035-06-30
Completion
2035-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591493 on ClinicalTrials.gov