Evidence map›Paper›PMID 35941566›Full record

Trial reportBMC cancer2022

Adjuvant therapy with gemcitabine and stereotactic body radiation therapy versus gemcitabine alone for resected stage II pancreatic cancer: a prospective, randomized, open-label, single center trial.

Tao Ma, Xueli Bai, Qichun Wei, Yongjie Shui, Mengyi Lao, Wen Chen, Bingfeng Huang, Risheng Que, Shunliang Gao, Yun Zhang and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02461836 (An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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.

NCT02461836 phase2unknown statusnot on this map

An Open-Labeled, Randomized Phase II Trial of Adjuvant Chemotherapy in Combination With Stereotactic Body Radiation Therapy (SBRT) Versus Adjuvant Chemotherapy Alone for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)

TypeinterventionalSponsorSecond Affiliated Hospital, Zhejiang University, School of MedicineRan2015 to 2020Enrolled513ConditionsPancreatic CancerArmsGemcitabine, SBRT
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Tao Ma *Department of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Xueli Bai *Department of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Qichun WeiDepartment of Radiation Oncology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Yongjie ShuiDepartment of Radiation Oncology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Mengyi LaoDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Wen ChenDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Bingfeng HuangDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Risheng QueDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Shunliang GaoDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Yun ZhangDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Wei ChenDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Ji WangDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China.
Tingbo LiangDepartment of Hepatobiliary and Pancreatic Surgery, Zhejiang Provincial Key Laboratory of Pancreatic Disease, the First Affiliated Hospital of Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 31003, China. liangtingbo@zju.edu.cn.
Zhejiang University · CNSecond Affiliated Hospital of Zhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of adjuvant radiation in pancreatic adenocarcinoma (PDAC) remains unclear. We aimed to investigate the efficacy of gemcitabine combined with stereotactic body radiation therapy (SBRT) as adjuvant therapy for resected stage II PDAC.

methodsIn this single-center randomized controlled trial, patients with stage II PDAC that underwent margin-negative resection were randomly assigned to gemcitabine-alone adjuvant chemotherapy or adjuvant SBRT followed by gemcitabine chemotherapy. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints included locoregional recurrence-free survival (LRFS), overall survival (OS), and incidence of adverse events.

resultsForty patients were randomly assigned to treatment between Sep 1, 2015 and Mar 31, 2018. Of these, 38 were included in the intention-to-treat analysis (20 in gemcitabine arm and 18 in gemcitabine plus SBRT arm). The median RFS and OS were 9.70, 28.0 months in the gemcitabine arm and 5.30, 15.0 months in the gemcitabine plus SBRT arm (RFS, P = 0.53; OS, P = 0.20), respectively. The median LRFS in both arms was unreached (P = 0.81). Grade 3 or 4 adverse events were all comparable between the two arms. Evaluation of data from the enrolled patients indicated that the addition of adjuvant SBRT was not associated with either better local disease control or recurrence-free survival.

conclusionsAdjuvant SBRT neither provided a survival benefit nor improved local disease control in resected stage II PDAC.

trial registrationClinicalTrials.gov, NCT02461836 . Registered 03/06/2015.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantDeoxycytidineGemcitabineHumansProspective StudiesDeoxycytidineGemcitabineAdjuvant therapyGemcitabinePancreatic adenocarcinomaRandomized controlled trialSBRT

Identifiers

PMID35941566
PMCPMC9361660
OpenAlexW4290673662

What OpenQuestion holds

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LicenceCC BY
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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.