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

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ClinicalTrials.gov Identifier: NCT04889742
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Sebastian Zschaeck, 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.

Condition or disease Intervention/treatment Phase
Recurrent Cancer Prostate Cancer Cervical Cancer Anal Cancer Sarcoma Rectal Cancer Neuroendocrine Tumors Esophageal Cancer Pancreas Cancer Squamous Cell Carcinoma Device: loco-regional hyperthermia Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2028


Arm Intervention/treatment
Experimental: 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.
Device: loco-regional hyperthermia
loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.




Primary Outcome Measures :
  1. Local tumor recurrence [ Time Frame: 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 :
  1. Overall survival [ Time Frame: 3 years ]
    Overall survival after start of re-irradiation

  2. Progression-free survival [ Time Frame: 3 years ]
    Progression-free survival after start of re-irradiation

  3. Freedom from distant metastases [ Time Frame: 3 years ]
    Freedom from distant metastases after start of re-irradiation

  4. Patient reported quality of Life [ Time Frame: 3 years ]
    patient reported quality of life measured by the EORTC qlq-c30 questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889742


Contacts
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Contact: Sebastian Zschaeck, MD +4930450650764 sebastian.zschaeck@charite.de

Locations
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Germany
Klinik für Radioonkologie und Strahlentherapie Recruiting
Berlin, Germany, 13353
Contact: Sebastian Zschaeck, M.D.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Sebastian Zschaeck, MD Charité
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Responsible Party: Sebastian Zschaeck, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04889742    
Other Study ID Numbers: HETERERO
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sebastian Zschaeck, Charite University, Berlin, Germany:
re-irradiation
hyperthermia
local recurrence
hyperthermic
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Anus Neoplasms
Pancreatic Neoplasms
Fever
Recurrence
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Anus Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Body Temperature Changes
Disease Attributes
Pathologic Processes