Hyperthermia European Adjuvant Trial (HEAT)

This study is currently recruiting participants.

Verified July 2012 by Klinikum der Universitaet Muenchen, Grosshadern

Sponsor:

Collaborators:

The European Society for Hyperthermic Oncology

Ludwig-Maximilians - University of Munich

Information provided by (Responsible Party):

Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern

ClinicalTrials.gov Identifier:

NCT01077427

First received: February 25, 2010

Last updated: July 18, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2010

Last Updated Date

July 18, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Disease-free survival (DFS) [ Time Frame: Interim analyses after 26 and 39 months after start of the study; final analysis after 60 months after start of the study; follow-up every 3 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01077427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause assessed up to 60 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Overall survival (OS) [ Time Frame: Interim analyses after 26 and 39 months after start of the study; final analysis after 60 months after start of the study; follow-up every 3 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Toxicity [ Time Frame: Permanent assessment ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: Permanent assessment ] [ Designated as safety issue: No ]
EORTC QLQ C30

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hyperthermia European Adjuvant Trial

Official Title ^ICMJE

A Randomized Two-armed Open Study on the Adjuvant Therapy in Patients With R0/R1 Resected Pancreatic Carcinoma With Gemcitabine Alone (Arm G) vs. Gemcitabine Plus Cisplatin With Regional Hyperthermia (Arm GPH)

Brief Summary

Improvement of the clinical outcome in patients with resectable pancreatic carcinoma through an intensified adjuvant treatment with additional application of cisplatin and regional deep hyperthermia.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Resected Pancreatic Adenocarcinoma

Intervention ^ICMJE

Device: Gemcitabine + Cisplatin + regional hyperthermia
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
Drug: Gemcitabine
Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)

Study Arm (s)

Active Comparator: Gemcitabine
Intervention: Drug: Gemcitabine
Experimental: Gemcitabine + Cisplatin + regional hyperthermia
Intervention: Device: Gemcitabine + Cisplatin + regional hyperthermia

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

336

Estimated Completion Date

March 2017

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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
Postoperative tumor marker (CEA/CA19-9) ≤ 2.5 x upper limit of normal (ULN) to be documented within 1 week prior to randomization
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
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

Exclusion criteria:

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
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
Gross adiposity defined as BMI > 40 kg/m²
Treatment with regional hyperthermia not possible for technical reasons (e.g. metal implant)

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rolf D. Issels, MD, PhD

+49-89-7095-7776

heat@med.uni-muenchen.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01077427

Other Study ID Numbers ^ICMJE

115-09, 2008-004802-14, AIO-PAK-0111

Has Data Monitoring Committee

Yes

Responsible Party

Rolf D. Issels, Klinikum der Universitaet Muenchen, Grosshadern

Study Sponsor ^ICMJE

Klinikum der Universitaet Muenchen, Grosshadern

Collaborators ^ICMJE

The European Society for Hyperthermic Oncology
Ludwig-Maximilians - University of Munich

Investigators ^ICMJE

Principal Investigator:

Rolf D. Issels, MD, PhD

Klinikum Grosshadern, Medical Center, University of Munich, Germany

Information Provided By

Klinikum der Universitaet Muenchen, Grosshadern

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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