Clinical trial · Interventional
Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
NCT04889742CI-TRIAL-00072524HETEREROnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Recurrent Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| loco-regional hyperthermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperthermia
- description
- 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.
- interventionNames
- Device: loco-regional hyperthermia
Primary outcomes (1)
- measure
- Local tumor recurrence
- timeFrame
- 3 years
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.