Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

NCT04889742 · tracked via the Priya Life Science Germany tracker

Sponsor

Charite University, Berlin, Germany

Phase

Phase 2

Started

2024-05-10

Last updated

2023-12-26

Condition(s) studied

Recurrent CancerProstate CancerCervical CancerAnal CancerSarcomaRectal CancerNeuroendocrine TumorsEsophageal CancerPancreas CancerSquamous Cell Carcinoma

Investigational drug(s) / intervention(s)

loco-regional hyperthermia

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

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Local tumor recurrence — 3 years
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.

Trial sites (1)

Facility	City	Region	Status
Klinik für Radioonkologie und Strahlentherapie	Berlin	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04889742 on ClinicalTrials.gov ↗ ← All trials in Germany