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A Prospective Study of Concurrent Hyperthermia, Chemotherapy and Radiotherapy in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT) (PANHEAT)

23. september 2026 oppdatert av: Pedro C Lara, Fernando Pessoa Canarias University

A Prospective Study of Concurrent Hyperthermia Plus Standard of Care in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)

The project proposes a prospective multicenter study to evaluate the incorporation of deep regional hyperthermia into the standard of care neoadjuvant chemotherapy (mFOLFIRINOX/NABPACLITAXEL) followed by radiotherapy in borderline and locally advanced ductal adenocarcinoma pancreatic cancer. Although current treatments, based on induction chemotherapy followed by surgery or radiotherapy in selected patients, have improved survival and resection rates, overall survival remains poor.

Hyperthermia is a therapeutic intensification strategy with a solid biological basis. By controlling tumor heating (39-43°C), it enhances the efficacy of chemotherapy and radiation therapy by improving tumor oxygenation, increasing perfusion, and inhibiting DNA damage repair, without adding significant systemic toxicity. The available clinical evidence, although based mainly on retrospective and small studies, suggests that the combination of HRP with multimodal treatments improves local control, favors conversion to surgery, and may prolong survival while maintaining a favorable safety profile.

The protocol contemplates the initial administration of induction chemotherapy (preferably mFOLFIRINOX or, alternatively, gemcitabine with nab-paclitaxel)plus hyperthermia followed by multidisciplinary reevaluation. Patients who deemed resectable will undergo surgery and adjuvant chemoradiotherapy and hyperthermia. Patients without metastatic progression who remain unresectable will receive SBRT in five fractions along with sessions of deep regional hyperthermia. Subsequently, the possibility of surgery will be assessed again and a standardized follow-up will be carried out with clinical, radiological, biochemical and pathological evaluation when appropriate.

The main objective of the study is to determine the impact of this strategy on overall survival. Secondary objectives will be to evaluate progression-free survival, local control, conversion rate to surgery, proportion of R0 resections, tumor response, safety, tolerability, and feasibility of treatment. With this, the study aims to provide prospective evidence on the role of hyperthermia as a therapeutic intensification strategy in localized pancreatic cancer.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Spania
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spania, 35010
        • Hospital Universitario de Gran Canaria Dr Negrín
        • Ta kontakt med:
    • Malaga
      • Málaga, Malaga, Spania

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Patients of borderline or Locally advanced pancreatic cancer

Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy/cytology).

ECOG performance scale 0 and 1.

Age between 18 and 80 years.

Adequate kidney functionality defined as creatinine clearance >50 ml/min.

Adequate liver functionality defined as total bilirubin ≤2 times of the upper limit of normal.

Adequate bone marrow reserves: WBC count ≥2.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin ≥8.0 g/L.

Women of child-bearing age must secure sufficient contraception control (dual protection with condoms and pills) during the clinical trial and 6 months after the clinical trial is completed.

For females of child bearing potential, pregnancy test within 2 week prior to randomization should be negative.

Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule.

Exclusion criteria

Absence of distant metastasis or gross peritoneal carcinomatosis.

Prior or concurrent malignancies.

Patients having metal implants, pacemakers or clustered markers.

Patients with metallic endobiliary stent would need to be replaced with plastic stents.

Any history of myocardial infarction within the past 12 months.

Any connective tissue disorder that contraindicate RT, e.g., scleroderma.

Pre-existing grade 2 peripheral neuropathy.

Any known contraindication or hypersensitivity to the chemotherapeutic agents used in the study as decided by the medical oncologists.

Pregnancy, lactation period or lack of reliable contraception.

Any other disease or therapy, which, according to the investigator, present a risk to the patient or which are not compatible with the aims of the clinical trial.

Indications that the person concerned will possibly not keep to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments.

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Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Hyperthermia plus neoadjuvant chemotherapy/radiotherapy

Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT
Enhet: Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp

Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
overall survival
Tidsramme: one year

Time from included in the study to death for any cause
one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: one year

Time from included in the study to disease progression
one year
Objective response rate (ORR)
Tidsramme: 6 months

according to RECIST 1.1.
6 months
disease control rate (DCR),
Tidsramme: 6 months

according to RECIST 1.1.
6 months
Biochemical response using CEA and CA 19-9.
Tidsramme: 6 months

Modifications CEA and CA19.9 values
6 months
Conversion rate to surgery.
Tidsramme: 6 months

Resectabiity after neoadjuvant treatment
6 months
R0 resection rate
Tidsramme: 7 months

Rate of complete resection in surgically treated patients
7 months
Pathological response, including ypTNM and GRT.
Tidsramme: 7 months

Pathological confirmed response after neoadjuvant treatment
7 months
Local progression-free survival as first cause of failure
Tidsramme: one year

Time from included in the study to local progression after treatment as first site of failure
one year
Acute and late toxicity chemotherapy and radiotherapy
Tidsramme: Acute: one month. Late: 12 months

Acute and late toxicity of treatment according to CTCAE v5.0.
Acute: one month. Late: 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fernando Pessoa Canarias University

Etterforskere

  • Hovedetterforsker: Pedro C Lara, Md, PhD, Universidad Fernando Pessoa Canarias

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

31. mars 2027

Primær fullføring (Antatt)

31. mars 2032

Studiet fullført (Antatt)

31. mars 2032

Datoer for studieregistrering

Først innsendt

13. september 2026

Først innsendt som oppfylte QC-kriteriene

23. september 2026

Først lagt ut (Faktiske)

24. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UFPC-26-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Data will be sharing under request due to ethic limitations

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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