Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Prostate Cancer Clinical Trial

— HETERERO  

Official title:

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04889742
• Other study ID #: HETERERO
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 10, 2024
• Est. completion date: January 2028

Study information

• Verified date: December 2023
• Source: Charite University, Berlin, Germany
• Contact: Sebastian Zschaeck, MD
• Phone: +4930450650764
• Email: sebastian.zschaeck[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Cervical Cancer
• Esophageal Cancer
• Fever
• Hyperthermia
• Neuroendocrine Tumors
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Rectal Cancer
• Recurrence
• Recurrent Cancer
• Sarcoma
• Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Radioonkologie und Strahlentherapie	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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