Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors (HETERERO)

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma; Cervical Cancer; Esophageal Cancer; Rectal Cancer; Prostate Cancer; Neuroendocrine Tumors; Pancreas Cancer; Anal Cancer; Squamous Cell Carcinoma; Recurrent Cancer
• Intervention / Treatment: Device: loco-regional hyperthermia

Detailed Description

patients that present a relapse within the previously irradiated volume can be included in this trial. These patients will receive re-irradiation according to clinical guidelines and hyperthermia as study intervention. According to tumor location hyperthermia can either be performed by microwave or by capacitive devices.

The primary endpoint of this study is non-inferiority of re-irradiation compared to the initial course of radiotherapy (calculated as time to local failure).

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sebastian Zschaeck, MD; Phone Number: +4930450650764; Email: sebastian.zschaeck@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Klinik für Radioonkologie und Strahlentherapie
    • Contact: Sebastian Zschaeck, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• prior radiotherapy of the treatment side with a treatment dose > 30 Gray (Gy) EQD2 (calculated with alpha/beta value of 9)
• local/ regional / or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy
• macroscopic tumor recurrence
• side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes)
• planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value of 9)

Exclusion Criteria:

• >3 macroscopic tumor lesion
• brain metastases
• recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
• recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
• contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
• psychiatric disorders that impede proper informed consent
• serious comorbidities with very limited prognosis quo ad vitam

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperthermia; Patients will receive 6-8 treatments additional loco-regional hyperthermia concurrent to re-irradiation. Hyperthermia will start on the third day of fractionated radiotherapy and will be given twice per week. According to site of recurrent disease either deep-regional, capacitive or superficial hyperthermia devices may be used.	Device: loco-regional hyperthermia; loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor recurrence	Local tumor recurrence of re-irradiated lesions, calculated with the Kaplan-Meier estimates. Local recurrence after hyperthermic re-irradiation will be compared to time-to recurrence after initial treatment.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival after start of re-irradiation	3 years
Progression-free survival	Progression-free survival after start of re-irradiation	3 years
Freedom from distant metastases	Freedom from distant metastases after start of re-irradiation	3 years
Patient reported quality of Life	patient reported quality of life measured by the EORTC qlq-c30 questionnaire.	3 years

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Sebastian Zschaeck, MD, Charite

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: hyperthermia; re-irradiation; local recurrence; hyperthermic
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Wounds and Injuries; Endocrine System Diseases; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Pancreatic Diseases; Body Temperature Changes; Heat Stress Disorders; Rectal Neoplasms; Anus Diseases; Recurrence; Pancreatic Neoplasms; Hyperthermia; Fever; Neuroendocrine Tumors; Anus Neoplasms
• Other Study ID Numbers: HETERERO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes