Clinical trial · Interventional
Neoadjuvant Treatment vs Upfront Surgery for Left-Sided Pancreatic Cancer
Neoadjuvant Treatment vs Upfront Surgery for Left Sided Pancreatic Cancer (LEFT-PANC) - a Study Protocol for a Prospective Randomized Multicenter Trial
- 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)
Pancreatic cancer is one of the most treatment resistant malignancies, often diagnosed at a late stage and associated with poor survival. The 5-year overall survival rate remains around 10%. Prognosis is affected by multiple factors including tumor stage, biology, treatment response, and anatomical location. Distal (left-sided) pancreatic cancer, originating from the body or tail of the pancreas, accounts for approximately 20-25% of all pancreatic cancers and has been associated with worse survival than pancreatic head cancer, even when adjusted for stage. This may be due to histological, molecular, and embryological differences, and varied systemic therapy responses. Neoadjuvant chemotherapy has become increasingly important in managing pancreatic cancer. It may improve outcomes by reducing tumor size, allowing for more complete (R0) resections, treating micrometastatic disease early, and identifying patients unlikely to benefit from surgery. While neoadjuvant therapy is recommended for borderline resectable and locally advanced tumors, randomized trials have not shown benefit for patients with upfront resectable pancreatic head cancer. Importantly, no randomized controlled trials have investigated the benefit of neoadjuvant treatment specifically in patients with upfront resectable left-sided pancreatic cancer, despite its distinct biology and worse prognosis. Retrospective data suggest neoadjuvant therapy may improve survival in left-sided tumors. A recent multicenter study reported significantly longer overall survival in patients treated with neoadjuvant therapy compared to upfront surgery alone. However, prospective randomized data are lacking. This multicenter randomized trial aims to assess whether patients with resectable left-sided pancreatic cancer benefit from neoadjuvant chemotherapy compared to upfront surgery. The study will reflect real-world clinical practice by allowing both commonly used regimens-FOLFIRINOX and Gemcitaine-Nab-paclitaxel -as neoadjuvant options. Previous studies have shown these regimens to be similarly effective, and switching between them due to toxicity or progression is feasible and does not seem to impair surgical outcomes or survival. This study aims to evaluate the benefits of neoadjuvant chemotherapy before surgery in a prospective multicenter randomized setting for resectable left-sided pancreatic cancer patients.
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 Resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Perioperative chemotherapy
- description
- Patients who undergo surgical resection will receive adjuvant chemotherapy with 4 cycles (2 months) of FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and 5-fluorouracil (400 mg/m2 bolus then 2400 mg/m2 over 46 h)) OR 2 cycles (2 months) of Gemcitabine 1000 mg/m2 over 30 min at day 1, 8, 15 of each 28-day cycle and capecitabine 830 mg/m2 ×2 daily for 3 weeks and one week rest of each 28-day cycle. Regimen changes due to toxicity are allowed. After 2 and 4 months of NAT, response imaging (multiphased body CT) is assessed at a local pancreatic MDT. If stable disease or regression is observed, patients will undergo surgery after chemotherapy break of 3-6 weeks. Adjuvant chemotherapy (2-4 months) must be started within 4-12 weeks after resection. Dose adjustments follow local practice; adjuvant therapy depends on patient condition (mFOLFIRINOX, Gem+capecitabine, or gemcitabine alone).
- interventionNames
- Drug: mFOLFIRINOX neoadjuvant chemotherapy / Nab-paclitaxel and gemcitabine
- type
- NO_INTERVENTION
- label
- Control arm
- description
- After randomization, arm B patients are scheduled for upfront surgery. Adjuvant chemotherapy of 6 months must be started within 4-12 weeks after resection. Dose reduction or dose delays are acted upon according to local clinical practice at each centre. The adjuvant therapy is decided and if necessary modified according to patient's condition (mFOLFIRINOX, Gem+cabecitabine, single Gem).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable left pancreatic cancer according to NCCN criteria * Written and informed consent * Age \> 18y * ECOG 0-2 * Fit for surgery * Fit for neoadjuvant chemotherapy Exclusion Criteria: * ECOG \> 2 * Histology other than ductal adenocarcinoma * Unable to give written consent * \< 18y
References
Publications (0)
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