Trial reportBMC cancer2018
Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group.
Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02047513 (Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer), which is not on this map. Cited by 26 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer: A Prospective, Randomized, Controlled, Phase II Study of the AIO (Working Group for Medical Oncology From the German Cancer Society) Pancreatic Cancer Group
Who cites it
26 citing papers in PubMed, 75 citations in OpenAlex.
- Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses.United European gastroenterology journal · 2020Trial
- Surrogate endpoints in clinical trials: when is good...good enough?Hepatobiliary surgery and nutrition · 2024Article
- Multimodal Approaches to Patient Selection for Pancreas Cancer Surgery.Current oncology (Toronto, Ont.) · 2024Review
- Article
- Review
- Association of Adjuvant Chemotherapy in Patients With Resected Pancreatic Adenocarcinoma After Multiagent Neoadjuvant Chemotherapy.JAMA oncology · 2023Article
- Risks and benefits of pancreaticoduodenectomy in patients aged 80 years and over.Langenbeck's archives of surgery · 2023Article
- Adaptive Dynamic Therapy and Survivorship for Operable Pancreatic Cancer.JAMA network open · 2022Article
- Baseline CT-based Radiomic Features Aid Prediction of Nodal Positivity after Neoadjuvant Therapy in Pancreatic Cancer.Radiology. Imaging cancer · 2022Article
- Short-Course or Total Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer - Current Status and Future Perspectives.Frontiers in surgery · 2022Review
- Stent Selection in Preoperative Biliary Drainage for Patients With Operable Pancreatic Cancer Receiving Neoadjuvant Therapy: A Meta-Analysis and Systematic Review.Frontiers in surgery · 2022Review
- Review
- Pancreatic cancer in 2021: What you need to know to win.World journal of gastroenterology · 2021Review
- UEG position paper on pancreatic cancer. Bringing pancreatic cancer to the 21st century: Prevent, detect, and treat the disease earlier and better.United European gastroenterology journal · 2021Review
- Advances in neoadjuvant therapy for resectable pancreatic cancer over the past two decades.Annals of hepato-biliary-pancreatic surgery · 2021Review
- Is Neoadjuvant Treatment Justified in Clinical T1 Pancreatic Ductal Adenocarcinoma?Journal of clinical medicine · 2021Article
- A phase I study of preoperative (neoadjuvant) chemotherapy with gemcitabine plusMolecular and clinical oncology · 2021Article
- Neoadjuvant Therapy (NAT) in Localized Pancreatic Cancer: Should We Do It and What Should We Do?Journal of cellular signaling · 2021Article
- Immunological combination treatment holds the key to improving survival in pancreatic cancer.Journal of cancer research and clinical oncology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEven clearly resectable pancreatic cancer still has an unfavorable prognosis. Neoadjuvant or perioperative therapies might improve the prognosis of these patients. Thus, evaluation of perioperative chemotherapy in resectable pancreatic cancer in a prospective, randomized trial is warranted. A substantial improvement in overall survival of patients with metastatic pancreatic cancer with FOLFIRINOX and nab-paclitaxel/gemcitabine vs standard gemcitabine has been demonstrated in phase III-trials. Indeed nab-paclitaxel/gemcitabine has a more favorable toxicity profile compared to the FOLFIRINOX protocol and appears applicable in a perioperative setting.
methodsNEONAX is an interventional, prospective, randomized, controlled, open label, two sided phase II study with an unconnected analysis of the results in both experimental arms against a fixed survival probability (38% at 18 months with adjuvant gemcitabine), NCT02047513. NEONAX will enroll 166 patients with resectable pancreatic ductal adenocarcinoma (≤ cT3, N0 or N1, cM0) in two arms: Arm A (perioperative arm): 2 cycles nab-paclitaxel (125 mg/m2)/gemcitabine (1000 mg/m2, d1, 8 and 15 of an 28 day-cycle) followed by tumor surgery followed by 4 cycles nab-paclitaxel/gemcitabine, Arm B (adjuvant arm): tumor surgery followed by 6 cycles nab-paclitaxel/gemcitabine. The randomization (1:1) is eminent to avoid allocation bias between the groups. Randomization is stratified for tumor stage (ct1/2 vs. cT3) and lymph node status (cN0 vs. cN1). Primary objective is disease free survival (DFS) at 18 months after randomization. Key secondary objectives are 3-year overall survival (OS) rate and DFS rate, progression during neoadjuvant therapy, R0 and R1 resection rate, quality of life and correlation of DFS, OS and tumor regression with pharmacogenomic markers, tumor biomarkers and molecular analyses (ctDNA, transcriptome, miRNA-arrays). In addition, circulating tumor-DNA will be analyzed in patients with the best and the worst responses to the neoadjuvant treatment. The study was initiated in March 2015 in 26 centers for pancreatic surgery in Germany. DISCUSSION: The NEONAX trial is an innovative study on resectable pancreatic cancer and currently one of the largest trials in this field of research. It addresses the question of the role of intensified perioperative treatment with nab-paclitaxel plus gemcitabine in resectable pancreatic cancers to improve disease-free survival and offers a unique potential for translational research.
trial registrationClinicalTrials.gov : NCT02047513, 08/13/2014.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.