Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

>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)

Trial design

Design model

Single group

Treatments tested in this trial

  • loco-regional hyperthermia

    Device

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

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: HyperthermiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years

Secondary outcomes

1

Overall survival

Overall survival after start of re-irradiation

Time frame
3 years
2

Progression-free survival

Progression-free survival after start of re-irradiation

Time frame
3 years
3

Freedom from distant metastases

Freedom from distant metastases after start of re-irradiation

Time frame
3 years
4

Patient reported quality of Life

patient reported quality of life measured by the EORTC qlq-c30 questionnaire.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: