Stage II seminoma is a type of cancer that is usually highly curable and most often affects young men.
Radiotherapy is an effective treatment, but it can sometimes cause side effects in the long term and, rarely, increase the risk of developing another cancer later in life.For this reason, more targeted treatments are being explored, such as proton therapy (PBT). This type of radiotherapy uses protons to better focus the treatment on the tumor while reducing exposure to the surrounding healthy tissues.The goal is to treat the cancer effectively while minimizing side effects as much as possible.
Age ≥ 18 years
Male gender
ECOG Performance status 0 - 1
Histologically confirmed diagnosis of testicular seminoma
Non-seminomatous germ cell tumor histology
Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
Prior or concurrent second malignancy other than non-melanoma skin cancer, unless disease free for a minimum of five years
Prior radiotherapy to the abdominal or pelvic region
Single group
protontherapy
Radiationpatients will be treated with protontherapy instead of radiotherapy with photon as standard of care
Treatment toxicities
Incidence of Grade ≥2 late treatment-related toxicity defined according to CTCAE v6.0 criteria
Progression free survival
Progression free survival within 12 months after radiotherapy defined defined as radiological progression and/or biochemical evidence of relapse, or death from any cause.
Modeled excess absolute risk (EAR) of secondary malignancies
estimated from individual organ dosimetry using validated dose-response models (exploratory, model-based component)
Overall survival
Overall survival at 3 years post-treatment defined by survival status of patients at each time point
Quality of life outcomes
evaluation of quality of life of patients through the completion of questionnarie QLQ-C30. Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life)
Values of circulating hsa-miR-371a-3p in patient treated with Proton Therapy
Evaluation of the change in circulating hsa-miR-371a-3p concentration (mg/dL) before and after experimental treatment. This tumor marker is being investigated as a potential biomarker for the early diagnosis of testicular cancer, and the aim is to analyze how it may be influenced by proton therapy by comparing it with standardized reference values.
Correlation between miRNA clearance/persistance and outcomes
analysis of plasma samples to evaluate the concentration of miRNA in plasma and how this could be linked to treatment outcomes
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Istituto Clinico Humanitas
Lead sponsor
AIRC (Italian Association for Cancer Research)
Collaborator
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