Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors (HETERERO)

Charité University Medicine Berlin

Status and phase: Not yet enrolling; Phase 2

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

Treatments: Device: loco-regional hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT04889742

HETERERO

Details and patient eligibility

About

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

Full 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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Hyperthermia

Experimental group

Description:

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.

Treatment:

Device: loco-regional hyperthermia