Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04889742

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Recurrent Cancer Anal Cancer Anus Diseases Anus Neoplasms Body Temperature Changes Carcinoma Carcinoma, Squamous Cell Cervical Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fever Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Head and Neck Neoplasms Heat Stress Disorders Hyperthermia Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Recurrence Sarcoma Signs and Symptoms Squamous Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinik für Radioonkologie und Strahlentherapie

Berlin, 13353, Germany

Location contact

Sebastian Zschaeck, M.D.

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

loco-regional hyperthermia

Device

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

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Zschaeck, MD

CONTACT

[email protected]

+4930450650764

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: HETERERO

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
May 17, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.