NCT04889742Not yet recruitingPhase 2
Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Source: ClinicalTrials.gov · Last updated 26 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 12 May 2021
- Start date
- 10 May 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Prostate cancer, Neuroendocrine tumours, Cervical cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Sarcoma
- NCT number
- NCT04889742
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 110
- From 10 May 2024 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
Other illness
- contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
- psychiatric disorders that impede proper informed consent
Other
- \>3 macroscopic tumor lesion
- brain metastases
- recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
- serious comorbidities with very limited prognosis quo ad vitam
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik für Radioonkologie und Strahlentherapie Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.