Resected Pancreatic AdenocarcinomaPhase 3HEATNCT01077427
Hyperthermia European Adjuvant Trial
A Phase 3 study testing Gemcitabine + Cisplatin + regional hyperthermia and Gemcitabine + Capecitabine in people with Resected Pancreatic Adenocarcinoma, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
Trial summary
Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resected Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine + Cisplatin + regional hyperthermia and Gemcitabine + Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any ductal adenocarcinoma of the pancreas confirmed by histology
- Previous R0 or R1 resection of pancreatic tumor with a standardized procedure
- No other previous or concomitant treatment of pancreatic carcinoma like radiation, neoadjuvant therapy or immunotherapy
- No tumor recurrence after surgery
- Performance status ECOG 0-2
- Adequate bone marrow function defined as
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- WBC count ≥ 3.5 x 109/L and
- platelets ≥ 150 x 109/L and
- haemoglobin ≥ 9 g/dl documented within 1 week prior to randomization
- Adequate renal function defined as
- serum creatinine ≤ 1.2 mg/dL and
- calculated GFR ≥ 60 mL/min documented within 1 week prior to randomization
- Adequate coagulatory function defined as
- Quick-value ≥ 70% and
- aPTT ≤ 1.5 x ULN documented within 1 week prior to randomization
- Transaminases (AST, ALT) ≤ 3 x ULN and bilirubin ≤ 2 x ULN documented within 1 week prior to randomization
- At least 18 years of age
- Women with childbearing potential and fertile men must use adequate contraceptive measures during and for at least 3 months (female) and 6 months (male) after completion of study therapy (Adequate methods for women are oral contraceptives with estrogen and progesterone, vaginal rings, contraceptive patches, estrogen-free ovulation inhibitors, intrauterine devices with progesterone, 3-month injections with depot progesterone, implants setting free progesterone, abstinence or sterilization (vasectomy) of the male partner. Men must use condoms.)
- Women with childbearing potential must have a negative pregnancy test within 1 week prior to randomization (postmenopausal women with amenorrhea for more than 1 year are regarded as having no childbearing potential)
- Written informed consent
Who cannot join
- Cystic carcinoma of the pancreas
- Periampullary, papillary cancer
- Metastatic disease
- Presence of an active infection grade 3 or higher
- Other severe disease which could impair the patient's ability to participate in the study according to the investigator's opinion
- Pregnant or breastfeeding women
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- Known allergies or contraindications with regard to substances or procedures of study therapy
- Severe, non-healing wounds, ulcers or bone fractures
- Participation in another clinical trial during this study or within 4 weeks prior to randomization (Exception: participation in a surgical trial prior to this study, for instance RECOPANC trial, comparing two different surgical procedures of pancreas resection)
- Past or current abuse of illegal or legal drugs or alcohol
- Other primary malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin).
- Permanent cardiac pacemaker
- Clinically significant cardiovascular or vascular disease or disorder ≤ 6 months before study enrolment (e.g. myocardial infarction, unstable angina pectoris, chronic heart failure NYHA ≥ grade 2, uncontrolled arrhythmia, cerebral infarction
- Gross adiposity defined as BMI > 40 kg/m²
- Treatment with regional hyperthermia not possible for technical reasons (e.g. metal implant)
- "Known documented dihydropyrimidine dehydrogenase (DPD) deficiency"
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Grosshadern, Medical Center, University of Munich
Munich, Bavaria, 81377
Rolf D. Issels, MD, PhD, +49-89-4400-77776, heat@med.uni-muenchen.de
Rolf D. Issels, MD, PhD
About this study
Official title: A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)
Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.
- Conditions
- Resected Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine + Cisplatin + regional hyperthermia, Gemcitabine + Capecitabine
- Keywords
- pancreatic cancer, adjuvant treatment, hyperthermia
- Medical subject headings
- Pancreatic Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine + Cisplatin + regional hyperthermiaDevice
Gemcitabine: 1000 mg/m² as iv-infusion on days 1 and 15 of each course (Total dose: 12 g/m²)
Cisplatin: 25 mg/m² as iv-infusion on days 2, 3* and 16, 17* of each course (Total dose: 600 mg/m²)
Regional hyperthermia: 60 minutes on days 2, 3*, and 16, 17* of each course
- as an exception for medical or logistic reasons RHT and cisplatin can be applied day 4 instead of 3 and day 18 instead of 17
Gemcitabine + CapecitabineDrug
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)
Capecitabine: daily dose of 1660 mg/m²; administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Capecitabine | Active comparator | Not described Receives: Drug: Gemcitabine + Capecitabine |
| Gemcitabine + Cisplatin + regional hyperthermia | Experimental | Not described Receives: Device: Gemcitabine + Cisplatin + regional hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (1)
Overall survival (OS)
Measured: From date of randomization until the date of death from any cause assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startMar 2012
- Primary completionMar 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resected Pancreatic AdenocarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universitaet Muenchen, Grosshadern
- Sponsor type
- University, hospital or other
- Collaborators
- The European Society for Hyperthermic Oncology, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern
- Investigators
- Rolf D. Issels, MD, PhD, Principal investigator, Klinikum Grosshadern, Medical Center, University of Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077427
- Sponsor's protocol ID
- 115-09
- Other IDs
- 2008-004802-14, AIO-PAK-0111, 2008
- Acronym
- HEAT
- Status last verified
- Nov 2017
- First submitted
- 25 Feb 2010
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 36657324
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Plus Capecitabine (Arm GC) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)
- ClinicalTrials.gov ID
- NCT01077427
- Acronym / sponsor ID
- HEAT / 115-09
- Conditions
- Resected Pancreatic Adenocarcinoma
- Keywords
- pancreatic cancer, adjuvant treatment, hyperthermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Klinikum der Universitaet Muenchen, GrosshadernUniversity, hospital or other
- Collaborators
- The European Society for Hyperthermic Oncology, Ludwig-Maximilians - University of Munich
- Study start
- Mar 2012
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 1 Mar 2010 (estimated)
- 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.
Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with gemcitabine, cisplatin and regional deep hyperthermia as compared to standard chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Capecitabine | Active comparator | Drug: Gemcitabine + Capecitabine |
| Gemcitabine + Cisplatin + regional hyperthermia | Experimental | Device: Gemcitabine + Cisplatin + regional hyperthermia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Any ductal adenocarcinoma of the pancreas confirmed by histology
- Previous R0 or R1 resection of pancreatic tumor with a standardized procedure
- No other previous or concomitant treatment of pancreatic carcinoma like radiation, neoadjuvant therapy or immunotherapy
- No tumor recurrence after surgery
- Performance status ECOG 0-2
Key exclusion criteria (16 listed)
- Cystic carcinoma of the pancreas
- Periampullary, papillary cancer
- Metastatic disease
- Presence of an active infection grade 3 or higher
- Other severe disease which could impair the patient's ability to participate in the study according to the investigator's opinion
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 |
|---|---|---|
| Gemcitabine + Cisplatin + regional hyperthermiaGemcitabine: 1000 mg/m² as iv-infusion on days 1 and 15 of each course (Total dose: 12 g/m²) Cisplatin: 25 mg/m² as iv-infusion on days 2, 3* and 16, 17* of each course (Total dose: 600 mg/m²) Regional hyperthermia: 60 minutes on days 2, 3*, and 16, 17* of each course * as an exception for medical or logistic reasons RHT and cisplatin can be applied day 4 instead of 3 and day 18 instead of 17 | Device | Gemcitabine + Cisplatin + regional hyperthermia |
| Gemcitabine + CapecitabineGemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²) Capecitabine: daily dose of 1660 mg/m²; administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles | Drug | Gemcitabine + Capecitabine |
Primary outcome
Disease-free survival (DFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
1 secondary outcome
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: 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.
- Pankreaszentrum MünchenLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Rolf D. Issels, MD, PhD principal investigator
Klinikum Grosshadern, Medical Center, University of Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine + Cisplatin + regional hyperthermia and Gemcitabine + Capecitabine in people with Resected Pancreatic Adenocarcinoma, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
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 20 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolf D. Issels, MD, PhD (+49-89-4400-77776, heat@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months). 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 NCT01077427, which also lists 1 linked publication.
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 17 Nov 2017.