Could chemo after surgery stop pancreatic tumor return?
NCT ID NCT07591493
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding chemotherapy after surgery can prevent aggressive pancreatic neuroendocrine tumors from coming back. About 300 patients will either receive active surveillance alone or 6 cycles of capecitabine-temozolomide pills plus surveillance. The study aims to see if chemo improves disease-free survival without a cure, as ongoing management is still needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Pathologically proven well differentiated neuro-endocrine tumour of the pancreas by local teams 2. Availability of the primary tumor specimen, allowing accurate WHO classification and determination of MGMT status 3. Stage I-III based ENETS-UICC 8th classification 4. Early postoperative context (≤ 4 months) 5. R0 resection 6. 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 7. ECOG 0-1 8. No prior systemic therapy 9. 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) 10. Age ≥ 18 years at the time of consent, no superior limit 11. Adequate bone marrow reserve (hemoglobine \> 8 g/dL, absolute neutrophils count ≥ 1500/mm³ and platelets ≥ 80 000/mm³) 12. Effective contraception 13. Written, dated and signed informed consent by the patient prior to any specific protocol procedure 14. Ability to comply with the protocol procedures 15. Patient affiliated to a social security system or beneficiary of the same Exclusion Criteria: 1. Poorly differentiated tumours (NEC) 2. Mixed NeuroEndocrine Non NeuroEndocrine tumors (MiNEN) 3. Neoadjuvant treatment or treatment with chemotherapy regimen used for another malignancy 4. Pregnant women or breastfeeding women 5. ECOG performance status \> 1 6. Age \< 18 years 7. PanNET arising in a genetic syndrome with other NETs already diagnosed (NF1, VHL or MEN) 8. 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 9. 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) 10. Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range 11. Current treatment with another investigational drug 12. Unrecovered toxicity from surgery 13. 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 14. Dihydropyrimidine dehydrogenase (DPD) deficiency or not done 15. Recent or concomitant treatment with brivudine 16. Hypersensitivity to Capecitabine or Temozolomide or to any of the excipients
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gustave Roussy
Villejuif, Île-de-France Region, 94800, France
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Other studies related to the condition(s) this trial covers.
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