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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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
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
Gustave Roussy
Villejuif, Île-de-France Region, France
Disease-free survival (DFS)
Time frame: time between randomization and the diagnosis of first recurrence or death, up to 5 years
Specific survival
Time frame: time from randomization to death due to disease progression, toxicity of the treatment or uncontrollable secretory syndrome, up to 5 years
Overall survival
Time frame: time from randomization to death from any cause, up to 5 years
Toxicity assessment
Time frame: at baseline, every month during the first year and then every year until the end of the study, up to 5 years
Time and pattern of recurrence
Time frame: time from randomization to the detection of recurrence, up to 5 years
Quality of life assessment
Time frame: evolution of the scores collected at baseline, every three months during one year, and then every year until the end of the study, up to 5 years
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