Hyperthermia Enhanced Re-irradiation Of Loco-regional Recurrent Tumors

Study Overview

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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

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).

Recurrent Cancer
Prostate Cancer
Cervical Cancer
Anal Cancer
Sarcoma
Rectal Cancer
Neuroendocrine Tumors
Esophageal Cancer
Pancreas Cancer
Squamous Cell Carcinoma

DEVICE: loco-regional hyperthermia

HETERERO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-12-19
First Submitted that Met QC Criteria 2021-05-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-12-26
First Posted (ACTUAL) 2021-05-17	Results First Posted N/A	Last Verified 2023-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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	DEVICE: loco-regional hyperthermia loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.

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

DEVICE: loco-regional hyperthermia

loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sebastian Zschaeck, MD

Phone Number: +4930450650764

Email: sebastian.zschaeck@charite.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

>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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Sebastian Zschaeck, MD, Charité

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record