Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04889742
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Charite University, Berlin, Germany
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sebastian Zschaeck, MD
Principal Investigator Affiliation	Charité
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Cancer, Prostate Cancer, Cervical Cancer, Anal Cancer, Sarcoma, Rectal Cancer, Neuroendocrine Tumors, Esophageal Cancer, Pancreas Cancer, Squamous Cell Carcinoma

Additional Details

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).

Arms & Interventions

Arms

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.

Interventions

Device: - loco-regional hyperthermia

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

Contact a Trial Team

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