Evidence map›Paper›PMID 33593311›Full record

ArticleBMC cancer2021

A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma.

Salvatore Paiella, Giuseppe Malleo, Nicola Simoni, Renato Micera, Stefania Guariglia, Carlo Cavedon, Giovanni Marchegiani, Alessandro Esposito, Luca Landoni, Luca Casetti and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04090463 (A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma), 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
0.2field-weighted citation impact, top 49% 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.

NCT04090463 phase2suspendednot on this map

A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma

TypeinterventionalSponsorUniversita di VeronaRan2019 to 2027Enrolled100ConditionsBorderline Resectable Pancreatic CancerArmsIntraoperative radiotherapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  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

20 authors at 1 institution in 1 country.

Salvatore Paiella *Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Giuseppe Malleo *Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Nicola SimoniUnit of Radiation Oncology, University of Verona Hospital Trust, Verona, Italy.
Renato MiceraUnit of Radiation Oncology, University of Verona Hospital Trust, Verona, Italy.
Stefania GuarigliaUnit of Medical Physics, University of Verona Hospital Trust, Verona, Italy.
Carlo CavedonUnit of Medical Physics, University of Verona Hospital Trust, Verona, Italy.
Giovanni MarchegianiUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Alessandro EspositoUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Luca LandoniUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Luca CasettiUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Massimiliano TuveriUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Michele MilellaUnit of Medical Oncology, University of Verona Hospital Trust, Verona, Italy.
Erica SecchettinUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Gessica ManziniUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Chiara BovoUniversity of Verona Hospital Trust Management Unit, Verona, Italy.
Matteo De PastenaUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Martina FontanaUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Roberto SalviaUnit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Renzo Mazzarotto *Unit of Radiation Oncology, University of Verona Hospital Trust, Verona, Italy.
Claudio Bassi *Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Policlinico Rossi, Piazzale L.A. Scuro 10, 37134, Verona, Italy. claudio.bassi@univr.it.
University of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes. METHODS/

designIn this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a "total neoadjuvant" therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting.

trial registrationNCT04090463 at clinicaltrials.gov.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyClinical Trials, Phase II as TopicCombined Modality TherapyFemaleFollow-Up StudiesHumansIntraoperative CareMaleMiddle AgedNeoadjuvant TherapyPancreatic NeoplasmsPrognosisIntraoperative radiotherapy (IORT)Locally advanced pancreatic cancerNeoadjuvant therapyPancreatic cancerStereotactic body radiation therapy (SBRT)

Identifiers

PMID33593311
PMCPMC7885611
OpenAlexW3131674949

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.