Pancreatic Neuroendocrine Tumors (pNET)Phase 3ADJUPANETNCT07591493
Adjuvant Trial in Pancreatic Neuroendocrine Tumors
A Phase 3 study testing Adjuvant chemotherapy with Capecitabine-Temozolomide and Active surveillance in people with Pancreatic Neuroendocrine Tumors (pNET) and Pancreatic Neuroendocrine Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumors (pNET), Pancreatic Neuroendocrine Tumors
- What is being tested?
- Adjuvant chemotherapy with Capecitabine-Temozolomide and Active surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Jun 2035
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- R0 resection
- Absence of distant metastasis or local tumor remnant as defined by a negative post-operative thorax CT and -abdomen CT or MRI and negative (best of DOTA-peptide 68Ga or, FDG) PET imaging if performed preoperatively
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- ECOG 0-1
- No prior systemic therapy
- Intermediate to high risk of recurrence as defined by the following situations:
- Ki67 ≥ 10% (i.e.: Grade 3 or high Ki67 Grade 2)
- Ki67 5-9% AND (tumor size > 3 cm OR Node positive)
- Ki67 3-5% AND tumor size > 3 cm AND Node positive
- Ki67 < 3% AND tumor size > 3 cm AND Node positive AND (Vascular Emboli OR perineural invasion)
- Age ≥ 18 years at the time of consent, no superior limit
- Adequate bone marrow reserve (hemoglobine > 8 g/dL, absolute neutrophils count ≥ 1500/mm³ and platelets ≥ 80 000/mm³)
- Effective contraception
- Written, dated and signed informed consent by the patient prior to any specific protocol procedure
- Ability to comply with the protocol procedures
- Patient affiliated to a social security system or beneficiary of the same
Who cannot join
- 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
- ECOG performance status > 1
- Age < 18 years
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- PanNET arising in a genetic syndrome with other NETs already diagnosed (NF1, VHL or MEN)
- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least five years
- Severe renal insufficiency (measured GFR according to MDRD < 30 ml/mn or nephrotic syndrome) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
- Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range
- Current treatment with another investigational drug
- Unrecovered toxicity from surgery
- Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the Investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- Dihydropyrimidine dehydrogenase (DPD) deficiency or not done
- Recent or concomitant treatment with brivudine
- Hypersensitivity to Capecitabine or Temozolomide or to any of the excipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Gustave Roussy
Villejuif, Île-de-France Region, 94800
Matthieu FARON, MD, 01 42 11 65 79 ext. +33, Matthieu.FARON@gustaveroussy.fr
About this study
Official title: First Adjuvant Trial in Locally Resected Aggressive Pancreatic Neuroendocrine Tumors: a Randomized Phase III Investigating the Efficacy of Systemic Chemotherapy
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.
- Being tested
- Adjuvant chemotherapy with Capecitabine-Temozolomide, Active surveillance
- Keywords
- R0 resected, stage I-III, CAPECITABINE, TEMOZOLOMIDE, active surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapy with Capecitabine-TemozolomideDrug
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 surveillanceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Active surveillance only Receives: Other: Active surveillance |
| Experimental group | Experimental | Adjuvant chemotherapy with Capecitabine-Temozolomide followed by active surveillance Receives: Drug: Adjuvant chemotherapy with Capecitabine-Temozolomide; Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: time between randomization and the diagnosis of first recurrence or death, up to 5 years
Secondary outcomes (5)
Specific survival
Measured: time from randomization to death due to disease progression, toxicity of the treatment or uncontrollable secretory syndrome, up to 5 years
Overall survival
Measured: time from randomization to death from any cause, up to 5 years
Toxicity assessment
Measured: 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
Measured: time from randomization to the detection of recurrence, up to 5 years
Quality of life assessment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2035 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine Tumors (pNET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591493
- Sponsor's protocol ID
- 2025-523593-16-00
- Other IDs
- 2025 / 4242, 2025
- Acronym
- ADJUPANET
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No