Seminoma
Conditions
Keywords
seminoma, cancer treatment, protontherapy, radiotherapy
Brief summary
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.
Interventions
RADIATIONprotontherapy
patients will be treated with protontherapy instead of radiotherapy with photon as standard of care
Sponsors
Istituto Clinico Humanitas
AIRC (Italian Association for Cancer Research)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Male gender * ECOG Performance status 0 - 1 * Histologically confirmed diagnosis of testicular seminoma * Stage IIA - IIB disease with metastatic involvement limited to retroperitoneal lymph nodes measuring ≤3 cm in greatest diameter * Prior radical orchiectomy * Clinical indication for radiotherapy * Written informed consent provided
Exclusion criteria
* 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 * Known severe, active co-morbidity * Inability or refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment toxicities | from enrollment to two years follow up | Incidence of Grade ≥2 late treatment-related toxicity defined according to CTCAE v6.0 criteria |
| Progression free survival | from enrollment to 12 months from treatment | 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 | from treatment to two years follow up | estimated from individual organ dosimetry using validated dose-response models (exploratory, model-based component) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | from treatment to three years follow up | Overall survival at 3 years post-treatment defined by survival status of patients at each time point |
| Quality of life outcomes | from treatment to two years follow up | 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 | from treatment to two years follow up | 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 | from treatment to two years follow up | analysis of plasma samples to evaluate the concentration of miRNA in plasma and how this could be linked to treatment outcomes |
| Quantification of immune cell populations according to cell type | from treatment to two years follow up | Evaluation of of systemic immune modulation through the analysis of concentration in plasma samples of immune cells |
Contacts
CONTACTCiro Franzese, MD, Radiation Oncologist
CONTACTLaura Bonavita, Master Degree
Outcome results
None listed