Evidence map›Paper›PMID 34405577›Full record

ArticleCancer medicine2021

Phase I study of dose-escalated stereotactic body radiation therapy for locally advanced pancreatic head cancers: Initial clinical results.

Shuiwang Qing, Lei Gu, Huojun Zhang

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02716207 (Mono-Center Phase ǀ Study on Dose Escalation of Stereotactic Body Radiotherapy), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT02716207 nacompletednot on this map

Mono-Center Phase ǀ Study on Dose Escalation of Stereotactic Body Radiotherapy (SBRT) Treating Pancreatic Cancer Patients With CyberKnife

TypeinterventionalSponsorChanghai HospitalRan2016 to 2020Enrolled16ConditionsPancreatic TumorArmsCyberKnife
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

3 authors.

Shuiwang QingDepartment of Radiation Oncology, The First Affiliated Hospital of Naval Military Medical University, Shanghai, China.
Lei GuDepartment of Radiation Oncology, The First Affiliated Hospital of Naval Military Medical University, Shanghai, China.
Huojun ZhangDepartment of Radiation Oncology, The First Affiliated Hospital of Naval Military Medical University, Shanghai, China.ORCID 0000-0002-1388-8163

Funding

Changhai Hospital Clinical Investigation Program 2019YPT004China Health Promotion Foundation THC 2015001National Key Research and Development Projects 2017YFC0113104Shenkang Center Innovation Research Program SHDC2020CR3087B
6 · The paper itself

Abstract

purposeTo establish the maximum tolerated dose (MTD) of stereotactic body radiation therapy (SBRT) for locally advanced pancreatic head cancers.

methodsA total of 16 patients were included in the single-institution phase I dose-escalation study. The initial dose level was 35 Gy in five fractions, doses were then sequentially escalated to 37.5 Gy, 40 Gy, 42.5 Gy, and 45 Gy. The dose-limiting toxicity (DLT) was defined as III/IV GI (gastrointestinal) toxicity.

resultsA total of 16 patients with locally advanced pancreatic head cancers were analyzed, 14 patients had received gemcitabine or S1-based chemotherapy. Median OS and LPFS were 14.5 months and 12.5 months, respectively; The OS rates at 1 and 2 years were 68.8% and 25%, respectively. No grade 3 or 4 acute or late GI toxicities were observed. Grade 3 toxicities were observed in four patients with three hematologic toxicities and one biliary obstruction for acute toxicities, G1-2 of GI late toxicity were in 31.25% of patients.

conclusionsSBRT doses ranging from 35 to 45 Gy in five fractions could be given for patients with locally advanced pancreatic head cancers without severe GI toxicities, whereas the side effect of biliary obstruction should be paid more attention.

trial registrationClinical trials:NCT02716207.

Indexed as

AdultDose Fractionation, RadiationFemaleHumansMaleMiddle AgedPancreatic NeoplasmsRadiosurgeryDLTdose-escalationGI toxicitypancreatic head cancerSBRT

Identifiers

PMID34405577
PMCPMC8495286

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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.