Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Phase 2

Not yet recruiting

• Conditions: Recurrent Cancer; Rectal Cancer; Neuroendocrine Tumors; Pancreas Cancer; Sarcoma; Prostate Cancer; Cervical Cancer; Anal Cancer; Esophageal Cancer; Squamous Cell Carcinoma
• Interventions: Device: loco-regional hyperthermia

• Registration Number: NCT04889742
• Lead Sponsor: Charite University, Berlin, Germany

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).

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26
• Study Start: 2024-05-10
• Primary Completion: 2026-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperthermia	loco-regional 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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Patient reported quality of Life	3 years	patient reported quality of life measured by the EORTC qlq-c30 questionnaire.
Overall survival	3 years	Overall survival after start of re-irradiation
Freedom from distant metastases	3 years	Freedom from distant metastases after start of re-irradiation
Progression-free survival	3 years	Progression-free survival after start of re-irradiation

Trial Locations

Locations (1)

Klinik für Radioonkologie und Strahlentherapie; 🇩🇪 Berlin, Germany