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
|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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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)|
|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|
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.
- 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.
- Overall survival [ Time Frame: 3 years ]Overall survival after start of re-irradiation
- Progression-free survival [ Time Frame: 3 years ]Progression-free survival after start of re-irradiation
- Freedom from distant metastases [ Time Frame: 3 years ]Freedom from distant metastases after start of re-irradiation
- Patient reported quality of Life [ Time Frame: 3 years ]patient reported quality of life measured by the EORTC qlq-c30 questionnaire.
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
|Contact: Sebastian Zschaeck, MDemail@example.com|
|Klinik für Radioonkologie und Strahlentherapie||Recruiting|
|Berlin, Germany, 13353|
|Contact: Sebastian Zschaeck, M.D.|
|Principal Investigator:||Sebastian Zschaeck, MD||Charité|