Clinical trial · Interventional
Adjuvant Versus Neoadjuvant Plus Adjuvant Chemotherapy in Resectable Pancreatic Cancer
Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study (NEOPAC Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low recruitment
Summary
Brief summary (as posted)
The outcome of patients with resected pancreatic cancer has significantly been improved by adjuvant chemotherapy. However, a large proportion of patients cannot receive adjuvant chemotherapy due to surgical complications. Neoadjuvant chemotherapy has been shown to be safe and effective and can be applied to all patients. This study should test neoadjuvant chemotherapy in a randomized manner. Patients with resectable cytologically proven adenocarinoma of the pancreatic head are randomized to arm A or B. Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with gemcitabine/oxaliplatin followed by surgery. Thereafter, all patients receive adjuvant gemcitabine for six months. Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A. The primary study-endpoint is the recurrence-free survival. Tumor recurrence are determined by computed tomography in a defined protocol. * Trial with medicinal product
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant chemotherapy with gemcitabine | Drug | — | UNRESOLVED |
| Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- neoadjuvant + adjuvant chemotherapy
- description
- neoadjuvant chemotherapy is based on gemcitabine/oxaliplatin adjuvant therapy is based on gemcitabine
- interventionNames
- Drug: Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- adjuvant chemotherapy
- description
- adjuvant therapy is based on gemcitabine
- interventionNames
- Drug: adjuvant chemotherapy with gemcitabine
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 9 months after inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy) * T1-3, Nx, M0 (UICC 6th version, 2002) * infiltration of the portal vein (\<180°) is not an exclusion criterion * cytologic or histologic confirmation of adenocarcinoma * age \>18 years * written informed consent Exclusion criteria: * contraindication for Whipple procedure * an infiltration \>180° of the portal vein * abutment of the tumor to the superior mesenteric artery * infiltration of the superior mesenteric artery or the celiac trunk * chronic neuropathy \> grade 2 * WHO performance score \>2 * uncorrectable cholestasis (bilirubin \> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion) * female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessary (IUP), condoms) * pregnant or lactating women * mental or organic disorders which could interfere with giving informed consent or receiving treatments * Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer * percutaneous biopsy of the primary tumor
References
Publications (1)
- DERIVEDHeinrich S, Pestalozzi B, Lesurtel M, Berrevoet F, Laurent S, Delpero JR, Raoul JL, Bachellier P, Dufour P, Moehler M, Weber A, Lang H, Rogiers X, Clavien PA. Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). BMC Cancer. 2011 Aug 10;11:346. doi: 10.1186/1471-2407-11-346. PMID 21831266