NCT07839676Not yet recruiting
A Prospective Study of Concurrent Hyperthermia, Chemotherapy and Radiotherapy in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
A Prospective Study of Concurrent Hyperthermia Plus Standard of Care in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- 31 Mar 2027
- Primary completion date
- 31 Mar 2032
- Lead sponsor
- Fernando Pessoa Canarias University
- Diseases
- Pancreatic cancer
- NCT number
- NCT07839676
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 31 Mar 2027 to the primary completion date, 31 Mar 2032
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent malignancies.
- Patients having metal implants, pacemakers or clustered markers.
Other illness
- Any history of myocardial infarction within the past 12 months.
- Any connective tissue disorder that contraindicate RT, e.g., scleroderma.
- Any known contraindication or hypersensitivity to the chemotherapeutic agents used in the study as decided by the medical oncologists.
- 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.
Other
- Absence of distant metastasis or gross peritoneal carcinomatosis.
- Patients with metallic endobiliary stent would need to be replaced with plastic stents.
- Pre-existing grade 2 peripheral neuropathy.
- Pregnancy, lactation period or lack of reliable contraception.
- 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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Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Gran Canaria Dr Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitario Quirón Salud Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.