๐ฌIn plain words
What the trial is, and whether it could suit you
Using moderate whole-body hyperthermia (mWBH) in tumor patients to see the influence on circulating tumor cells, tumor response, quality of life, fatigue, psyche, immune response and tumor microenvironment
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* The general condition of the patients must be sufficient for multimodal treatment (corresponding to WHO status 0-2)
* Tumordisease in a palliative setting of the following 6 groups:
1. Malignant melanoma, treatment-naive stage IV with multiple metastases and missing BRAF-V600 mutation. With indication for initiation of immunotherapy using PD-1 and CTLA-4 antibody therapy.
2. Patients with metastatic or inoperable pancreatic cancer, who are planning first-line chemotherapy with FOLFIRINOX is.
3. Patients with an indication for palliative radiation therapy extracranial, tumor manifestation with a prescribed radiation dose of 30 to 36 Gy due to hormone receptor-positive carcinoma of the breast, patients must have at least one additional (marker) lesion not treated with radiation.
4. Patients with metastatic high-grade sarcoma for whom metastasis-directed ablative therapy methods are not possible and palliative first-line therapy with doxorubicin.
5. Patients with metastatic or loco-regionally recurrent HPV-associated squamous cell carcinoma (of the head and neck region, cervix, anus or vulva) for whom local therapies are not possible and for whom palliative first-line therapy containing platinum is planned.
6. Patients with metastatic, castration-resistant prostate cancer, with progressive disease after exceeding the recommended therapy options for which a therapy attempt with lutetium-177-PSMA was indicated.
Exclusion Criteria:
* Presence of contraindications to simultaneous chemotherapy or whole-body hyperthermia
* Serious or active comorbidities that could interfere with treatment or understanding of the nature and content of the study, for example:
* Chronic inflammatory bowel disease
* Acute infections
* Serious cardiovascular or pulmonary comorbidities
* Mental illnesses, showing the proper Study participation or recording the nature of the study to make impossible
* Presence of cerebral metastasis
* Diabetes mellitus with risk of end-organ damage
๐
What it tests
- moderate Whole Body Hyperthermia (mWBH)
Klinik fรผr Radioonkologie und Strahlentherapie
Berlin, Germany
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.