NCT02439593: HEATPAC

Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study

Status unknown Phase 2 Last updated 1 August 2017

What this trial tests

Phase 2 trial testing Chemoradiotherapy (CTRT) in Cancer Pancreas in 78 participants. Status unknown.

Timeline

1 January 2017

Primary endpoint
30 June 2021

31 December 2021

Quick facts

Lead sponsor	Kantonsspital Aarau
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	1 January 2017
Primary completion	30 June 2021
Estimated completion	31 December 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Chemoradiotherapy (CTRT)
• Thermochemoradiotherapy (CTRTHT)

Conditions studied

• Cancer Pancreas — all drugs for Cancer Pancreas →

Sponsor

Kantonsspital Aarau — full company profile →

Who can join

Adults 18 to 80, any sex, with Cancer Pancreas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia (study group) versus chemoradiotherapy alone (control group) following neoadjuvant chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39 patients based on the expected overall 1 year survival advantage of +20% over the control group (p0=40%).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy, Radiotherapy, and Hyperthermia: A Combined Therapeutic Approach in Pancreatic Cancer Treatment.
   Mahmood J, Shukla HD, Soman S, Samanta S, et al · · 2018 · cited 43× · PMID 30486519 · DOI 10.3390/cancers10120469
2. "HEATPAC" - a phase II randomized study of concurrent thermochemoradiotherapy versus chemoradiotherapy alone in locally advanced pancreatic cancer.
   Datta NR, Pestalozzi B, Clavien PA, Siebenhüner A, et al · · 2017 · cited 23× · PMID 29162142 · DOI 10.1186/s13014-017-0923-8
3. Locoregional therapies and their effects on the tumoral microenvironment of pancreatic ductal adenocarcinoma.
   Lambin T, Lafon C, Drainville RA, Pioche M, et al · · 2022 · cited 13× · PMID 35645539 · DOI 10.3748/wjg.v28.i13.1288
4. The addition of deep hyperthermia to gemcitabine-based chemoradiation may achieve enhanced survival in unresectable locally advanced adenocarcinoma of the pancreas.
   Rogers SJ, Datta NR, Puric E, Timm O, et al · · 2021 · cited 8× · PMID 33598571 · DOI 10.1016/j.ctro.2021.01.008
5. Are Aspects of Integrative Concepts Helpful to Improve Pancreatic Cancer Therapy?
   Oei SL, Schad F. · · 2023 · cited 5× · PMID 36831465 · DOI 10.3390/cancers15041116
6. Evidence based tools to improve efficiency of currently administered oncotherapies for tumors of the hepatopancreatobiliary system.
   Herold Z, Szasz AM, Dank M. · · 2021 · cited 5× · PMID 34616516 · DOI 10.4251/wjgo.v13.i9.1109
7. Successes and Failures of Combined Modalities in Upper Gastrointestinal Malignancies: New Directions.
   Jamorabo DS, Lin SH, Jabbour SK. · · 2016 · cited 1× · PMID 27619252 · DOI 10.1016/j.semradonc.2016.05.001
8. The role of hyperthermia in modern radiation treatment- state of art.
   Borkowska A, Chmiel P, Rutkowski P, Spałek MJ. · · 2025 · PMID 41390436 · DOI 10.1186/s13014-025-02741-5