Trial reportJournal of gastroenterology2019
A single-arm, phase II trial of neoadjuvant gemcitabine and S1 in patients with resectable and borderline resectable pancreatic adenocarcinoma: PREP-01 study.
Trial report in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- Comparison Between Plastic and Metallic Biliary Stent Placement for Preoperative Patients with Pancreatic Head Cancer: A Systematic Review and Meta-Analysis.Annals of surgical oncology · 2024Pooled it
- Pooled it
- Trial
- Article
- Evaluating preoperative gemcitabine-based chemoradiation for resectable and borderline resectable pancreatic cancer: a phase 1 study.Fukushima journal of medical science · 2026Article
- Outcomes of Resected Cases of Pancreatic Ductal Adenocarcinoma Patients With Unexpected Postoperative Uncovering Noncurative Factors: A Multicenter Retrospective Study.Annals of gastroenterological surgery · 2026Article
- Limited benefits of neoadjuvant therapy on R0 resection rate and overall survival in patients with resectable or locally advanced PDAC in randomized controlled trials.Frontiers in medicine · 2026Review
- FecalGastro hep advances · 2026Article
- Surgery based on resectability status of pancreatic cancer: a narrative review.Japanese journal of clinical oncology · 2025Review
- Oncological outcome of surgical resection for anaplastic carcinoma of the pancreas.Molecular and clinical oncology · 2025Article
- Dynamic changes in tumor blood flow during chemotherapy: Implications in customized treatment for pancreatic cancer.Oncology letters · 2025Article
- Favorable Response Defined by CA19-9 Reduction After Neoadjuvant Treatment for Pancreatic Cancer.Annals of surgical oncology · 2025Article
- Clinical efficacy and chemoresistance analysis of precision neoadjuvant chemotherapy for borderline resectable pancreatic cancer: a prospective, single-arm pilot study.International journal of surgery (London, England) · 2025Article
- Neoadjuvant Treatment with Changes in Chemotherapy Regimens According to Carbohydrate Antigen 19-9 Level for Resectable/Borderline Resectable Pancreatic Ductal Adenocarcinoma.Annals of surgical oncology · 2025Article
- Optimal treatment strategy for patients with pancreatic cancer having positive peritoneal cytology: A nationwide multicenter retrospective cohort study supervised by the Japanese Society of Hepato-Biliary-Pancreatic Surgery.Journal of hepato-biliary-pancreatic sciences · 2025Article
- The impact of preoperative renal insufficiency on the outcomes of patients with pancreatic cancer undergoing pancreaticoduodenectomy.Langenbeck's archives of surgery · 2024Article
- Effectiveness of endoscopic ultrasound-guided tissue acquisition with stereomicroscopic on-site evaluation for preoperative diagnosis of resectable or borderline resectable pancreatic cancer: a prospective study.Clinical endoscopy · 2024Article
- Clinical significance of postoperative complications after pancreatic surgery in time-to-complication and length of postoperative hospital stay: a retrospective study.Langenbeck's archives of surgery · 2024Article
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Corrections and comments
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Authors and funding
10 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundNeoadjuvant chemotherapy (NAC) represents a promising alternative to pancreatic ductal adenocarcinoma (PDAC) planned resection, but the survival impact remains undefined. To assess the feasibility and survival outcomes of NAC with gemcitabine and S1 (GS) for PDAC planned resection by prospective study.
methodsPatients with resectable or borderline resectable PDAC received 2 cycles of NAC-GS and were offered curative resection followed by gemcitabine adjuvant. The primary endpoint was 2-year overall survival (OS). Adverse events during NAC, radiological and tumor marker responses, resection rate, and surgical safety were evaluated as secondary endpoints (UMIN000004148).
resultsWe enrolled 104 patients between 2010 and 2012, with 101 patients treated using NAC-GS as the full analysis set (FAS). Of the 101 patients, 88% received the planned 2 cycles of NAC. Grade 3 neutropenia was common (35%). Radiological partial response and decreased carbohydrate antigen 19-9 concentration (> 50% decrease) were noted in 13% and 41%, respectively. R0/1 resections with M0 were performed in 65 patients without surgical mortality. Of the 65 patients, 44 received planned gemcitabine adjuvant for 6 months as the on-protocol cohort. The primary endpoint for the 2-year OS rate was 55.9% in the FAS (n = 101) and 74.6% in the on-protocol cohort (n = 44).
conclusionsNAC-GS was feasible and actively prolonged survival following PDAC planned resection. Randomized control trials are needed to further clarify the survival benefit of NAC-GS in addition to surgery followed by adjuvant therapy.
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