MedDataX Logo

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

NCT ID: NCT04889742

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

re-irradiation hyperthermia local recurrence hyperthermic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

loco-regional hyperthermia

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

loco-regional hyperthermia

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sebastian Zschaeck

MD, PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebastian Zschaeck, MD

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinik für Radioonkologie und Strahlentherapie

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sebastian Zschaeck, MD

Role: CONTACT

Phone: +4930450650764

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sebastian Zschaeck, M.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HETERERO

Identifier Type: -

Identifier Source: org_study_id