Evidence map›Paper›PMID 29462005›Full record

Trial reportAnnals of surgery2018

Oncological Benefits of Neoadjuvant Chemoradiation With Gemcitabine Versus Upfront Surgery in Patients With Borderline Resectable Pancreatic Cancer: A Prospective, Randomized, Open-label, Multicenter Phase 2/3 Trial.

Jin-Young Jang, Youngmin Han, Hongeun Lee, Sun-Whe Kim, Wooil Kwon, Kyung-Hun Lee, Do-Youn Oh, Eui Kyu Chie, Jeong Min Lee, Jin Seok Heo and 10 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIComparative Study
PubMed Publisher
In one paragraph

Trial report in Annals of surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 347 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
347citing papers in PubMed, 8 pooled it
26.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT04289792 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial

TypeinterventionalSponsorFujian Medical University Union HospitalRan2020 to 2025Enrolled27ConditionsPancreatic NeoplasmsArmsnab-Paclitaxel+Gemcitabine, split-course SBRT
NCT04855331 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer: An Multicenter Open-label Randomized Clinical Trial

TypeinterventionalSponsorFudan UniversityRan2021 to 2025Enrolled120ConditionsBorderline Resectable Pancreatic CancerArmsLaparoscopic pancreatoduodenectomy, Open pancreatoduodenectomy
3 · Its place in the literature

Who cites it

347 citing papers in PubMed, 8 syntheses or guidelines pooled it, 671 citations in OpenAlex.

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287 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 6 institutions in 1 country.

Jin-Young JangDepartment of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Youngmin HanDepartment of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Hongeun LeeDepartment of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Sun-Whe KimDepartment of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Wooil KwonDepartment of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Kyung-Hun LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Do-Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Eui Kyu ChieDepartment of Radiation Oncology, Seoul National University Hospital, Seoul, Republic of Korea.
Jeong Min LeeDepartment of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.
Jin Seok HeoDepartment of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Joon Oh ParkDepartment of Internal Medicine Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Do Hoon LimDepartment of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Seong Hyun KimDepartment of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Sang Jae ParkCenter for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
Woo Jin LeeCenter for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
Young Hwan KohCenter for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
Joon Seong ParkDepartment of Surgery, Gangnam Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea.
Dong Sup YoonDepartment of Surgery, Gangnam Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea.
Ik Jae LeeDepartment of Radiation Oncology, Yonsei University Health System, Seoul, Republic of Korea.
Seong Ho ChoiDepartment of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Seoul National University Hospital · KRSungkyunkwan University · KRNational Cancer Center · KRYonsei University Health System · KRGangnam Severance Hospital · KRSamsung Medical Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study was performed to determine whether neoadjuvant treatment increases survival in patients with BRPC. SUMMARY BACKGROUND DATA: Despite many promising retrospective data on the effect of neoadjuvant treatment for borderline resectable pancreatic cancer (BRPC), no high-level evidence exists to support the role of such treatment.

methodsThis phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.

resultsAfter excluding the patients who withdrew consent (n = 8) from the 58 enrolled patients, 27 patients were allocated to neoadjuvant treatment and 23 to upfront surgery groups. The overall 2-YSR was 34.0% with a median survival of 16 months. In the intention-to-treat analysis, the 2-YSR and median survival were significantly better in the neoadjuvant chemoradiation than the upfront surgery group [40.7%, 21 months vs 26.1%, 12 months, hazard ratio 1.495 (95% confidence interval 0.66-3.36), P = 0.028]. R0 resection rate was also significantly higher in the neoadjuvant chemoradiation group than upfront surgery (n = 14, 51.8% vs n = 6, 26.1%, P = 0.004). The safety monitoring committee decided on early termination of the study on the basis of the statistical significance of neoadjuvant treatment efficacy.

conclusionThis is the first prospective randomized controlled trial on the oncological benefits of neoadjuvant treatment in BRPC. Compared to upfront surgery, neoadjuvant chemoradiation provides oncological benefits in patients with BRPC.

Indexed as

Chemoradiotherapy, AdjuvantNeoadjuvant TherapyPancreatectomyAdolescentAdultAgedAntineoplastic AgentsCarcinoma, Pancreatic DuctalDeoxycytidineFemaleGemcitabineHumansIntention to Treat AnalysisMaleMiddle AgedPancreatic NeoplasmsAntineoplastic AgentsDeoxycytidineGemcitabine

Identifiers

PMID29462005
OpenAlexW2912196744

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.