A Phase 2 interventional study of loco-regional hyperthermia in Recurrent Cancer, Prostate Cancer and Cervical Cancer, sponsored by Charite University, Berlin, Germany. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Charite University, Berlin, Germany · Phase 2, Interventional, and Treatment
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).
4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 3,429 interventional studies indexed under Recurrence.
Browse Recurrence studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
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.
Time frame: 3 years
Overall survival
Overall survival after start of re-irradiation
Time frame: 3 years
Progression-free survival
Progression-free survival after start of re-irradiation
Time frame: 3 years
Freedom from distant metastases
Freedom from distant metastases after start of re-irradiation
Time frame: 3 years
Patient reported quality of Life
patient reported quality of life measured by the EORTC qlq-c30 questionnaire.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Jan 2026, 20 months later.
Of 409 non-industry phase 2 interventional studies under Recurrence, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 85. This study's planned 20 months is below that.
Counting every sponsor, half of 499 studies reached it within 49 months; a quarter within 31 and three quarters within 78.
Recurrence covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →