Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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

Detailed Description
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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).

Official Title
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Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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

Intervention / Treatment
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* Device: loco-regional hyperthermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperthermia<br>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<br>* loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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re-irradiation, hyperthermia, local recurrence, hyperthermic