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Adjuvant Trial in Pancreatic Neuroendocrine Tumors

ConditionsPancreatic Neuroendocrine Tumors (pNET)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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Adjuvant chemotherapy with Capecitabine-Temozolomide

    Drug

    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

    Other intervention

    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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Disease-free survival (DFS)

Time frame
time between randomization and the diagnosis of first recurrence or death, up to 5 years

Secondary outcomes

1

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
2

Overall survival

Time frame
time from randomization to death from any cause, up to 5 years
3

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
4

Time and pattern of recurrence

Time frame
time from randomization to the detection of recurrence, up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: