Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

NCT04889742 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: HETERERO
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Cancer; Prostate Cancer; Cervical Cancer; Anal Cancer; Sarcoma; Rectal Cancer; Neuroendocrine Tumors; Esophageal Cancer; Pancreas Cancer; Squamous Cell Carcinoma

Keywords

re-irradiation; hyperthermia; local recurrence; hyperthermic

Outcome Measures

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.

  3 years

Secondary Outcomes (4)

• Overall survival

  3 years

• Progression-free survival

  3 years

• Freedom from distant metastases

  3 years

• Patient reported quality of Life

  3 years

Study Arms (1)

Hyperthermia

EXPERIMENTAL

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

Interventions

loco-regional hyperthermia DEVICE

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

Hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \>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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Klinik für Radioonkologie und Strahlentherapie

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Recurrence; Prostatic Neoplasms; Uterine Cervical Neoplasms; Anus Neoplasms; Sarcoma; Rectal Neoplasms; Neuroendocrine Tumors; Esophageal Neoplasms; Pancreatic Neoplasms; Carcinoma, Squamous Cell; Hyperthermia; Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Sebastian Zschaeck, MD

  Charité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Zschaeck, MD

CONTACT

+4930450650764; sebastian.zschaeck@charite.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PI

Model Details: Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: May 10, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)