Evidence map›Paper›PMID 29162142›Full record

Trial reportRadiation oncology (London, England)2017

"HEATPAC" - a phase II randomized study of concurrent thermochemoradiotherapy versus chemoradiotherapy alone in locally advanced pancreatic cancer.

Niloy Ranjan Datta, Bernhard Pestalozzi, Pierre-Alain Clavien, Alexander Siebenhüner, Emsad Puric, Shaka Khan, Christoph Mamot, Oliver Riesterer, Jürg Knuchel, Cäcilia Sophie Reiner and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02439593 (A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT02439593 phase2unknown statusnot on this map

A Phase II Randomized Study of Concurrent Hyperthermia and Chemoradiotherapy vs. Chemoradiotherapy Alone Following Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer (HEATPAC)

TypeinterventionalSponsorKantonsspital AarauRan2017 to 2021Enrolled78ConditionsCancer PancreasArmsChemoradiotherapy (CTRT), Thermochemoradiotherapy (CTRTHT)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Hyperthermia combined with chemotherapyWorld journal of clinical oncology · 2023
    Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Heating technology for malignant tumors: a review.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 2020
    Review
  15. Radiotherapy for Melanoma: More than DNA Damage.Dermatology research and practice · 2019
    Review
  16. Review
  17. Review
  18. Observational
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 2 institutions in 1 country.

Niloy Ranjan DattaCentre for Radiation Oncology KSA-KSB, Kantonsspital Aarau AG, Tellstrasse, CH-5001, Aarau, Switzerland. niloyranjan.datta@ksa.ch.
Bernhard PestalozziCentre for Hematology and Oncology, University Hospital Zurich, Zürich, Switzerland.
Pierre-Alain ClavienDepartment of Surgery and Transplantation, University Hospital Zurich, Zürich, Switzerland.
Alexander SiebenhünerCentre for Hematology and Oncology, University Hospital Zurich, Zürich, Switzerland.
Emsad PuricCentre for Radiation Oncology KSA-KSB, Kantonsspital Aarau AG, Tellstrasse, CH-5001, Aarau, Switzerland.
Shaka KhanCentre for Radiation Oncology KSA-KSB, Kantonsspital Aarau AG, Tellstrasse, CH-5001, Aarau, Switzerland.
Christoph MamotCentre for Medical Oncology / Hematology, Kantonsspital, Aarau, Switzerland.
Oliver RiestererDepartment of Radiation Oncology, University Hospital Zurich, Zürich, Switzerland.
Jürg KnuchelDepartment of Gastroenterology and Hepatology, Kantonsspital, Aarau, Switzerland.
Cäcilia Sophie ReinerInstitute for Diagnostic and Interventional Radiology, University Hospital Zurich, Zürich, Switzerland.
Stephan BodisCentre for Radiation Oncology KSA-KSB, Kantonsspital Aarau AG, Tellstrasse, CH-5001, Aarau, Switzerland.
members of the HEATPAC Trial Group
University Hospital of Zurich · CHKantonsspital Aarau · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPancreatic cancer has a dismal prognosis with 5-year overall survival rate of around 5%. Although surgery is still the best option in operable cases, majority of the patients who present in locally advanced stages are deemed inoperable. Novel approaches are therefore needed for the management of around 80% of these inoperable locally advanced pancreatic cancers (LAPC). Hyperthermia (39-43 °C) is a potent radiosensitizer and further enhances the action of gemcitabine, also a known radiosensitizer. Thus through triple sensitization, a combination of hyperthermia, radiotherapy and gemcitabine could be expected to improve the therapeutic outcomes in LAPC.

methodsThis phase II randomized trial, HEATPAC in unresectable LAPC, explores the feasibility and efficacy of concurrent thermochemoradiotherapy (HTCTRT) over chemoradiotherapy (CTRT) alone with pre- and post-intervention FOLFIRINOX at standard dosage and schedule. Following 4 cycles of neoadjuvant FOLFIRINOX, patients with no metastasis and absence of gross peritoneal carcinomatosis would be randomized to either (a) control arm: concurrent CTRT with gemcitabine (400 mg/m DISCUSSION: The expected 1-year baseline overall survival with CTRT alone is considered as 40%. With HTCTRT, a survival advantage of +20% is expected. Considering α = 0.05 and β = 0.80 for sample size computation, a total of 86 patients would be equally randomized into the two treatment groups. This phase II study if found to be safe and effective, would form the basis of a future phase III randomized study.

trial registrationThe trial has been registered with the ClinicalTrials.gov ( NCT02439593 ). The study has been approved by the Ethical Commissions of Basel and Zurich and is open for patient recruitment.

Indexed as

AdolescentAdultAgedAged, 80 and overChemoradiotherapyDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansHyperthermia, InducedMaleMiddle AgedNeoplasm MetastasisPancreatic NeoplasmsRadiation-Sensitizing AgentsDeoxycytidineGemcitabineRadiation-Sensitizing AgentsChemotherapyHyperthermiaPancreatic cancersRadiotherapyRandomized trialStudy protocol

Identifiers

PMID29162142
PMCPMC5698973
OpenAlexW2768972958

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.