Anal Cancer, Cervical Cancer, Esophageal Cancer, Neuroendocrine Tumors, Pancreas Cancer, Prostate Cancer, Rectal Cancer, Recurrent Cancer, Sarcoma, Squamous Cell Carcinoma
Conditions
Keywords
re-irradiation, hyperthermia, local recurrence, hyperthermic
Brief summary
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
Detailed description
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).
Interventions
DEVICEloco-regional hyperthermia
loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local tumor recurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | Overall survival after start of re-irradiation |
| Progression-free survival | 3 years | Progression-free survival after start of re-irradiation |
| Freedom from distant metastases | 3 years | Freedom from distant metastases after start of re-irradiation |
| Patient reported quality of Life | 3 years | patient reported quality of life measured by the EORTC qlq-c30 questionnaire. |
Countries
Germany
Contacts
Primary ContactSebastian Zschaeck, MD
Outcome results
None listed