Clinical trial NCT04889742: Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Official title: Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Recurrent Cancer
Prostate Cancer
Cervical Cancer
Anal Cancer
Sarcoma
Rectal Cancer
Neuroendocrine Tumors
Esophageal Cancer
Pancreas Cancer
Squamous Cell Carcinoma
Keywords: re-irradiation
hyperthermia
local recurrence
hyperthermic
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Local tumor recurrence
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Freedom from distant metastases
timeFrame: 3 years
measure: Patient reported quality of Life
timeFrame: 3 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Radioonkologie und Strahlentherapie
Study officials:
affiliation: Charité
name: Sebastian Zschaeck, MD
role: PRINCIPAL_INVESTIGATOR
References: