Borderline and Locally Advanced Pancreatic CancerPANHEATNCT07839676
A Prospective Study of Concurrent Hyperthermia, Chemotherapy and Radiotherapy in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
A study testing Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp in people with Borderline and Locally Advanced Pancreatic Cancer, run by Fernando Pessoa Canarias University at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Borderline and Locally Advanced Pancreatic Cancer
- What is being tested?
- Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 31 Mar 2027to 31 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Hospital Universitario de Gran Canaria Dr Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Laura Ferrera-Alayón, MD, Phd, +34928450000, lferala@gobiernodecanarias.org
Hospital Universitario Quirón Salud
Málaga, Malaga
Jorge Contreras, MD, PhD, +34 951 94 00 00, jorgecontrerasmartinez@gmail.com
About this study
Official title: 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.
Read more
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.
- Being tested
- Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp
- Keywords
- Hyperthermia, borderline, locally advanced, pancreatic cancer, chemotherapy, radiotherapy
- Medical subject headings
- Hyperthermia, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: HypDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia plus neoadjuvant chemotherapy/radiotherapy | Experimental | Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT Receives: Device: Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Time from included in the study to death for any cause
Measured: one year
Secondary outcomes (9)
Progression Free Survival
Time from included in the study to disease progression
Measured: one year
Objective response rate (ORR)
according to RECIST 1.1.
Measured: 6 months
disease control rate (DCR),
according to RECIST 1.1.
Measured: 6 months
Biochemical response using CEA and CA 19-9.
Modifications CEA and CA19.9 values
Measured: 6 months
Conversion rate to surgery.
Resectabiity after neoadjuvant treatment
Measured: 6 months
R0 resection rate
Rate of complete resection in surgically treated patients
Measured: 7 months
Pathological response, including ypTNM and GRT.
Pathological confirmed response after neoadjuvant treatment
Measured: 7 months
Local progression-free survival as first cause of failure
Time from included in the study to local progression after treatment as first site of failure
Measured: one year
Acute and late toxicity chemotherapy and radiotherapy
Acute and late toxicity of treatment according to CTCAE v5.0.
Measured: Acute: one month. Late: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start31 Mar 2027 (estimated)
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline and Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando Pessoa Canarias University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro C Lara, Fernando Pessoa Canarias University
- Investigators
- Pedro C Lara, Md, PhD, Principal investigator, Universidad Fernando Pessoa Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839676
- Sponsor's protocol ID
- UFPC-26-01
- Acronym
- PANHEAT
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be sharing under request due to ethic limitations
Publications
Issels RD, Boeck S, Pelzer U, Mansmann U, Ghadjar P, Lindner LH, Albertsmeier M, Angele MK, Schmidt M, Xu Y, Bahra M, Pratschke J, Schoenberg M, Thasler WE, Salat C, Stoetzer OJ, Knoefel WT, Graf D, Wessalowski R, Keitel-Anselmino V, Koenigsrainer A, Bitzer M, Zips D, Bamberg M, Fietkau R, Ott O, Kawecki M, Wyrwicz L, Rutkowski P, Rentsch M, Ababei J, Reichardt P, Rigamonti M, Weber B, Abdel-Rahman S, Tschoep-Lechner K, Jauch KW, Bruns CJ, Oettle H, von Bergwelt-Baildon M, Heinemann V, Werner J; European Society for Hyperthermic Oncology (ESHO) and the German Arbeitsgemeinschaft Internistische Onkologie (AIO) Study Group for Pancreatic Cancer. Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial. Eur J Cancer. 2023 Mar;181:155-165. doi: 10.1016/j.ejca.2022.12.009. Epub 2022 Dec 30.
PubMed 36657324Datta NR, Pestalozzi B, Clavien PA, Siebenhuner A, Puric E, Khan S, Mamot C, Riesterer O, Knuchel J, Reiner CS, Bodis S; members of the HEATPAC Trial Group. "HEATPAC" - a phase II randomized study of concurrent thermochemoradiotherapy versus chemoradiotherapy alone in locally advanced pancreatic cancer. Radiat Oncol. 2017 Nov 21;12(1):183. doi: 10.1186/s13014-017-0923-8.
PubMed 29162142
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Concurrent Hyperthermia Plus Standard of Care in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
- ClinicalTrials.gov ID
- NCT07839676
- Acronym / sponsor ID
- PANHEAT / UFPC-26-01
- Keywords
- Hyperthermia, borderline, locally advanced, pancreatic cancer, chemotherapy, radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fernando Pessoa Canarias UniversityUniversity, hospital or other
- Study start
- 31 Mar 2027 (estimated)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia plus neoadjuvant chemotherapy/radiotherapy | Experimental | Device: Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: HypHyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: HypHyperthermia 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 | Device | Hyperthermia plus neoadjuvant chemotherapy/radiotherapy |
Primary outcome
overall survival
Time frame: one year
Time from included in the study to death for any cause
9 secondary outcomes
Progression Free Survival
Time frame: one year
Objective response rate (ORR)
Time frame: 6 months
disease control rate (DCR),
Time frame: 6 months
Biochemical response using CEA and CA 19-9.
Time frame: 6 months
Conversion rate to surgery.
Time frame: 6 months
R0 resection rate
Time frame: 7 months
Pathological response, including ypTNM and GRT.
Time frame: 7 months
Local progression-free survival as first cause of failure
Time frame: one year
Acute and late toxicity chemotherapy and radiotherapy
Time frame: Acute: one month. Late: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 36657324Issels RD, Boeck S, Pelzer U, Mansmann U, Ghadjar P, Lindner LH, Albertsmeier M, Angele MK, Schmidt M, Xu Y, Bahra M, Pratschke J, Schoenberg M, Thasler WE, Salat C, Stoetzer OJ, Knoefel WT, Graf D, Wessalowski R, Keitel-Anselmino V, Koenigsrainer A, Bitzer M, Zips D, Bamberg M, Fietkau R, Ott O, Kawecki M, Wyrwicz L, Rutkowski P, Rentsch M, Ababei J, Reichardt P, Rigamonti M, Weber B, Abdel-Rahman S, Tschoep-Lechner K, Jauch KW, Bruns CJ, Oettle H, von Bergwelt-Baildon M, Heinemann V, Werner J; European Society for Hyperthermic Oncology (ESHO) and the German Arbeitsgemeinschaft Internistische Onkologie (AIO) Study Group for Pancreatic Cancer. Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial. Eur J Cancer. 2023 Mar;181:155-165. doi: 10.1016/j.ejca.2022.12.009. Epub 2022 Dec 30.
- Background: PubMed 29162142Datta NR, Pestalozzi B, Clavien PA, Siebenhuner A, Puric E, Khan S, Mamot C, Riesterer O, Knuchel J, Reiner CS, Bodis S; members of the HEATPAC Trial Group. "HEATPAC" - a phase II randomized study of concurrent thermochemoradiotherapy versus chemoradiotherapy alone in locally advanced pancreatic cancer. Radiat Oncol. 2017 Nov 21;12(1):183. doi: 10.1186/s13014-017-0923-8.
- Individual participant dataSharing planned: No. Data will be sharing under request due to ethic limitations
Related trials for Borderline and Locally Advanced Pancreatic Cancer
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Active, not recruitingEarly Phase 1
CEB-01 in Locally Resectable Pancreatic Cancer
Pancreatic Carcinoma
RecruitingPhase 1
PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
Recruiting
Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment
Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
RecruitingPhase 1
AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer
Borderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro C Lara, Md, PhD principal investigator
Universidad Fernando Pessoa Canarias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp in people with Borderline and Locally Advanced Pancreatic Cancer, run by Fernando Pessoa Canarias University at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro C Lara, MD, PhD (+34928012800, plara@ufpcanarias.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07839676, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.