NCT01077427

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
336

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

7 years

First QC Date

February 25, 2010

Last Update Submit

November 14, 2017

Conditions

Resected Pancreatic Adenocarcinoma

Keywords

pancreatic canceradjuvant treatmenthyperthermia

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    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)

    From date of randomization until the date of death from any cause assessed up to 60 months

Other Outcomes (2)

  • Toxicity

    Permanent assessment

  • Quality of Life

    Permanent assessment

Study Arms (2)

Gemcitabine + Capecitabine

ACTIVE COMPARATOR
Drug: Gemcitabine + Capecitabine

Gemcitabine + Cisplatin + regional hyperthermia

EXPERIMENTAL
Device: Gemcitabine + Cisplatin + regional hyperthermia

Interventions

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 + Cisplatin + regional hyperthermia
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

Gemcitabine + Capecitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +5 more criteria

You may not qualify if:

  • 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
  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Grosshadern, Medical Center, University of Munich

Munich, Bavaria, 81377, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36657324DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsHyperthermia

Interventions

GemcitabineCapecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Rolf D. Issels, MD, PhD

    Klinikum Grosshadern, Medical Center, University of Munich, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolf D. Issels, MD, PhD

CONTACT

+49-89-4400-77776heat@med.uni-muenchen.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 1, 2010

Study Start

March 1, 2012

Primary Completion

March 1, 2019

Study Completion

March 1, 2021

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

DE(1)