Clinical trial · Interventional
NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
NCT01521702CI-TRIAL-00017196NEOPACcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy). This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
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 |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| surgery and Adjuvant chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy
- description
- After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11).
- interventionNames
- Drug: Neoadjuvant chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- surgery
- description
- surgery
- interventionNames
- Procedure: surgery and Adjuvant chemotherapy
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
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 pessars (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 (0)
Data not yet available
No reference posted for this study.