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2024-05-10
2026-01
2028-01
110
NCT04889742
Charite University, Berlin, Germany
Charite University, Berlin, Germany
INTERVENTIONAL
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.
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-05-12 | N/A | 2023-12-19 |
2021-05-12 | N/A | 2023-12-26 |
2021-05-17 | N/A | 2023-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/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 | DEVICE: loco-regional hyperthermia
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival after start of re-irradiation | 3 years |
| Progression-free survival | Progression-free survival after start of re-irradiation | 3 years |
| Freedom from distant metastases | Freedom from distant metastases after start of re-irradiation | 3 years |
| Patient reported quality of Life | patient reported quality of life measured by the EORTC qlq-c30 questionnaire. | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sebastian Zschaeck, MD Phone Number: +4930450650764 Email: sebastian.zschaeck@charite.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
