Evidence map›Paper›PMID 37403011›Full record

ArticleBMC cancer2023

Triple modal treatment comprising with proton beam radiation, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer: a phase I/II study protocol (TT-LAP trial).

Osamu Shimomura, Masato Endo, Hirokazu Makishima, Takeshi Yamada, Shinji Hashimoto, Haruko Numajiri, Yoshihiro Miyazaki, Manami Doi, Kinji Furuya, Kazuhiro Takahashi and 16 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  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

26 authors at 2 institutions in 1 country.

Osamu Shimomura *Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan.
Masato Endo *Department of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Hirokazu Makishima *Department of Radiation oncology, University of Tsukuba, Ibaraki, Japan.
Takeshi YamadaDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Shinji HashimotoDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan.
Haruko NumajiriDepartment of Radiation oncology, University of Tsukuba, Ibaraki, Japan.
Yoshihiro MiyazakiDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan.
Manami DoiDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan.
Kinji FuruyaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan.
Kazuhiro TakahashiDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan.
Toshikazu MoriwakiDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Naoyuki HasegawaDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Yoshiyuki YamamotoDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Yusuke NiisatoDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Mariko KobayashiDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Masashi MizumotoDepartment of Radiation oncology, University of Tsukuba, Ibaraki, Japan.
Kei NakaiDepartment of Radiation oncology, University of Tsukuba, Ibaraki, Japan.
Takashi SaitoDepartment of Radiation oncology, University of Tsukuba, Ibaraki, Japan.
Sodai HoshiaiDepartment of Radiology, University of Tsukuba, Ibaraki, Japan.
Tsukasa SaidaDepartment of Radiology, University of Tsukuba, Ibaraki, Japan.
Bryan J MathisInternational Medical Center, University of Tsukuba Hospital, Ibaraki, Japan.
Kensaku MoriDepartment of Radiology, University of Tsukuba, Ibaraki, Japan.
Takahito NakajimaDepartment of Radiology, University of Tsukuba, Ibaraki, Japan.
Kiichiro TsuchiyaDepartment of Gastroenterology, University of Tsukuba, Ibaraki, Japan.
Hideyuki SakuraiDepartment of Radiation oncology, University of Tsukuba, Ibaraki, Japan.
Tatsuya OdaDepartment of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, 305-8575, Japan. tatoda@md.tsukuba.ac.jp.
University of Tsukuba · JPUniversity of Tsukuba Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLocally advanced pancreatic ductal adenocarcinoma (PDAC), accounting for about 30% of PDAC patients, is difficult to cure by radical resection or systemic chemotherapy alone. A multidisciplinary strategy is required and our TT-LAP trial aims to evaluate whether triple-modal treatment with proton beam therapy (PBT), hyperthermia, and gemcitabine plus nab-paclitaxel is a safe and synergistically effective treatment for patients with locally advanced PDAC.

methodsThis trial is an interventional, open-label, non-randomized, single-center, single-arm phase I/II clinical trial organized and sponsored by the University of Tsukuba. Eligible patients who are diagnosed with locally advanced pancreatic cancer, including both borderline resectable (BR) and unresectable locally advanced (UR-LA) patients, and selected according to the inclusion and exclusion criteria will receive triple-modal treatment consisting of chemotherapy, hyperthermia, and proton beam radiation. Treatment induction will include 2 cycles of chemotherapy (gemcitabine plus nab-paclitaxel), proton beam therapy, and 6 total sessions of hyperthermia therapy. The initial 5 patients will move to phase II after adverse events are verified by a monitoring committee and safety is ensured. The primary endpoint is 2-year survival rate while secondary endpoints include adverse event rate, treatment completion rate, response rate, progression-free survival, overall survival, resection rate, pathologic response rate, and R0 (no pathologic cancer remnants) rate. The target sample size is set at 30 cases. DISCUSSION: The TT-LAP trial is the first to evaluate the safety and effectiveness (phases1/2) of triple-modal treatment comprised of proton beam therapy, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer. ETHICS AND DISSEMINATION: This protocol was approved by the Tsukuba University Clinical Research Review Board (reference number TCRB22-007). Results will be analyzed after study recruitment and follow-up are completed. Results will be presented at international meetings of interest in pancreatic cancer plus gastrointestinal, hepatobiliary, and pancreatic surgeries and published in peer-reviewed journals.

trial registrationJapan Registry of Clinical Trials, jRCTs031220160. Registered 24 th June 2022, https://jrct.niph.go.jp/en-latest-detail/jRCTs031220160 .

Indexed as

Carcinoma, Pancreatic DuctalHyperthermia, InducedPancreatic NeoplasmsAlbuminsAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicGemcitabineHumansPaclitaxelProtons130-nm albumin-bound paclitaxelAlbuminsGemcitabinePaclitaxelProtonsClinical trialHyperthermiaLocally advanced pancreatic cancerMultidisciplinary treatmentProton beam therapy

Identifiers

PMID37403011
PMCPMC10320973
OpenAlexW4383102833

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.