Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

  • STATUS
    Recruiting
  • End date
    Jan 23, 2028
  • participants needed
    110
  • sponsor
    Charite University, Berlin, Germany
Updated on 23 May 2021
recurrent disease

Summary

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

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).

Details
Condition oesophageal carcinoma, Carcinoma, Prostate Cancer, Early, Recurrent, anal carcinoma, soft tissue sarcomas, neuroendocrine tumors, Prostate Cancer, cancer of the esophagus, sarcomas, All Solid Tumors, oesophageal cancer, Neuroectodermal Tumor, Vulvar Dysplasia and Carcinoma, Connective and Soft Tissue Neoplasm, Colorectal Cancer, head and neck cancer, cervical carcinoma, Squamous Cell Carcinoma, cervix cancer, Cervical Cancer, squamous cell cancer, Sarcoma, cervical cancer, uterine, pancreatic cancers, esophagus cancer, Neurectoderma, Anal Cancer, Head and Neck Cancer, Esophageal Disorders, Prostatic disorder, Esophageal Carcinoma, carcinoma of the cervix uteri, Rectal Cancer, carcinoma of cervix, epidermoid carcinoma, prostate cancers, Uterine Cancer, Soft Tissue Sarcoma, Neuroendocrine Tumor, cancer of the pancreas, carcinoma of the cervix, neuroendocrine tumour, Recurrent Carcinoma, Prostate Disorders, rectal carcinoma, Malignant neoplasm of prostate, cancer, pancreatic, Colon Cancer Screening, Esophageal Cancer, Disorders of cervix NOS, Pancreatic Cancer, Recurrent Cancer, Advanced Malignancies, Solid Tumors, Squamous cell carcinoma, prostate carcinoma, Colon cancer; rectal cancer, cancer of the cervix, Esophageal Diseases, Uterine Serous Carcinoma, Sarcoma (Pediatric), Islet Ce417ll Cancer
Treatment loco-regional hyperthermia
Clinical Study IdentifierNCT04889742
SponsorCharite University, Berlin, Germany
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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