Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · May 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent cancer who have already received radiation therapy in the past. The researchers want to see if using heat (called hyperthermia) along with radiation therapy can help improve outcomes for patients with tumors that have come back after previous treatment. The trial will include patients with various types of recurrent cancers, including prostate, cervical, and rectal cancers, among others.

To be eligible for the trial, participants must have had prior radiation treatment on the same side of their body where their cancer has returned, with a specific dose of radiation. They should have up to three visible tumors, with at least one previously treated with radiation, and the location of the tumors must be suitable for the heat treatment. Participants can expect to receive a new combination of therapies that aim to target their cancer more effectively. It's important to know that this trial is not yet recruiting participants, and there are specific health conditions that may prevent someone from joining, such as having too many tumors or certain medical devices.

Gender

ALL

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