Evidence map›Paper›PMID 30825970›Full record

ArticleRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2019

Phase I trial of concurrent stereotactic body radiotherapy and nelfinavir for locally advanced borderline or unresectable pancreatic adenocarcinoma.

Chi Lin, Vivek Verma, Quan P Ly, Audrey Lazenby, Aaron Sasson, James K Schwarz, Jane L Meza, Chandrakanth Are, Sicong Li, Shuo Wang and 2 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01068327 (A Phase 1 Study of Hypofractionated Stereotactic Radiotherapy and Concurrent HIV Protease Inhibitor Nelfinavir as Part of a Neoadjuvant Regimen in Patients With Locally Advanced Pancreatic Cancer), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.1field-weighted citation impact, top 18% 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.

NCT01068327 phase1completednot on this map

A Phase 1 Study of Hypofractionated Stereotactic Radiotherapy and Concurrent HIV Protease Inhibitor Nelfinavir as Part of a Neoadjuvant Regimen in Patients With Locally Advanced Pancreatic Cancer

TypeinterventionalSponsorUniversity of NebraskaRan2007 to 2015Enrolled46ConditionsAdenocarcinoma of the Pancreas, Stage III Pancreatic CancerArmsgemcitabine hydrochloride, leucovorin calcium, fluorouracil, nelfinavir mesylate, stereotactic body radiation therapy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 31 citations in OpenAlex.

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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

12 authors at 5 institutions in 1 country.

Chi LinDepartment of Radiation Oncology, University of Nebraska Medical Center, Omaha, USA. Electronic address: clin@unmc.edu.
Vivek VermaDepartment of Radiation Oncology, Allegheny General Hospital, Pittsburgh, USA.
Quan P LyDepartment of Surgery, University of Nebraska Medical Center, Omaha, USA.
Audrey LazenbyDepartment of Pathology, University of Nebraska Medical Center, Omaha, USA.
Aaron SassonDepartment of Surgery, Stony Brook School of Medicine, Stony Brook, USA.
James K SchwarzDepartment of Internal Medicine, Division of Hematology Oncology, University of Nebraska Medical Center, Omaha, USA.
Jane L MezaDepartment of Biostatistics, University of Nebraska Medical Center, Omaha, USA.
Chandrakanth AreDepartment of Surgery, University of Nebraska Medical Center, Omaha, USA.
Sicong LiDepartment of Radiation Oncology, University of Nebraska Medical Center, Omaha, USA.
Shuo WangDepartment of Radiation Oncology, University of Nebraska Medical Center, Omaha, USA.
Stephen M HahnDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
Jean L GremDepartment of Internal Medicine, Division of Hematology Oncology, University of Nebraska Medical Center, Omaha, USA.
University of Nebraska Medical Center · USAllegheny General Hospital · USNebraska Medical Center · USStony Brook School · USThe University of Texas MD Anderson Cancer Center · US

Funding

Tissue CoreP50CA127297 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI HOLLINGSWORTH, MICHAEL A. · 2008 to 2018
$17.1M
NCI NIH HHS P50 CA127297
6 · The paper itself

Abstract

introductionThe HIV protease inhibitor nelfinavir (NFV) displays notable radiosensitizing effects. There have been no studies evaluating combined stereotactic body radiotherapy (SBRT) and NFV for borderline/unresectable pancreatic cancer. The primary objective of this phase I trial (NCT01068327) was to determine the maximum tolerated SBRT/NFV dose, and secondarily evaluate outcomes.

methodsFollowing initial imaging, pathologic confirmation, and staging laparoscopy, subjects initially received three 3-week cycles of gemcitabine/leucovorin/fluorouracil; patients without radiologic progression received 5-fraction SBRT/NFV. Dose escalation was as follows: (1) 25 Gy/625 mg BID ×3wks; (2) 25 Gy/1250 mg BID ×3wks; (3) 30 Gy/1250 mg BID ×3wks; (4) 35 Gy/1250 mg BID ×3wks; (5) 35 Gy/1250 mg BID ×5wks; and (6) 40 Gy/1250 mg BID ×5wks. Pancreaticoduodenectomy was performed thereafter if resectable; if not, gemcitabine/leucovorin/fluorouracil was administered.

resultsForty-six patients enrolled (10/2008-5/2013); 39 received protocol-directed therapy. Sixteen (41%) experienced any grade ≥2 event during and 1 month after SBRT. Four grade 3 and both grade 4 events occurred in a single patient at the initial dose level. 40 Gy/1250 mg BID ×5wks was the maximum tolerated dose. Five patients had late gastrointestinal bleeding (n = 2 superior mesenteric artery pseudo-aneurysm, n = 1 disease progression, n = 1 lower GI tract, n = 1 unknown location). The median overall survival was 14.4 months. Six (15%) patients recurred locally; median local failure-free survival was not reached. The median distant failure-free survival was 11 months, and median all failure-free survival was 10 months.

conclusionsConcurrent SBRT (40 Gy)/NFV (1250 mg BID) for locally advanced pancreatic cancer is feasible and safe, although careful attention to treatment planning parameters is recommended to reduce the incidence of late gastrointestinal bleeding.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapy, AdjuvantDeoxycytidineDisease ProgressionFemaleFluorouracilGemcitabineHumansLeucovorinMaleMiddle AgedNelfinavirNeoadjuvant TherapyDeoxycytidineFluorouracilGemcitabineLeucovorinNelfinavirRadiation-Sensitizing AgentsNelfinavirPancreasPancreatic cancerStereotactic body radiation therapy

Identifiers

PMID30825970
PMCPMC6400311
OpenAlexW2906529963

What OpenQuestion holds

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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.