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| ID | Type | Description | Link |
|---|---|---|---|
| IG 2025 ID 32742 | Other Grant/Funding Number | AIRC |
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| Name | Class |
|---|---|
| Associazione Italiana per la Ricerca sul Cancro | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protontherapy Treatment | Experimental | patient will be treated with protontherapy instead of radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protontherapy | Radiation | patients will be treated with protontherapy instead of radiotherapy with photon as standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment toxicities | Incidence of Grade ≥2 late treatment-related toxicity defined according to CTCAE v6.0 criteria | from enrollment to two years follow up |
| 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. | from enrollment to 12 months from treatment |
| Modeled excess absolute risk (EAR) of secondary malignancies | estimated from individual organ dosimetry using validated dose-response models (exploratory, model-based component) | from treatment to two years follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival at 3 years post-treatment defined by survival status of patients at each time point | from treatment to three years follow up |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ciro Franzese, MD, Radiation Oncologist | Contact | +39 0282247454 | ciro.franzese@hunimed.eu | |
| Laura Bonavita, Master Degree | Contact | +39 0282247026 | laura.bonavita@humanitas.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40588561 | Background | Marelli G, Morina N, Puccio S, Iovino M, Pandini M, Portale F, Carvetta M, Mishra D, Diana E, Meregalli G, Paraboschi E, Cibella J, Peano C, Basso G, De Simone G, Camisaschi C, Magrini E, Sartori G, Karimi E, Colombo P, Lazzeri M, Casale P, Morosi L, Martano G, Asselta R, Bonavita E, Matsunami H, Bertoni F, Walsh L, Lugli E, Di Mitri D. Chemosensor receptors are lipid-detecting regulators of macrophage function in cancer. Nat Immunol. 2025 Jul;26(7):1182-1197. doi: 10.1038/s41590-025-02191-x. Epub 2025 Jun 30. | |
| 39672156 |
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| ID | Term |
|---|---|
| D018239 | Seminoma |
| ID | Term |
|---|---|
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| from treatment to two years follow up |
| 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. | from treatment to two years follow up |
| 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 | from treatment to two years follow up |
| Quantification of immune cell populations according to cell type | Evaluation of of systemic immune modulation through the analysis of concentration in plasma samples of immune cells | from treatment to two years follow up |
| Quality of life outcomes | evaluation of quality of life of patients through the completion of questionnarie QLQ-TC26. Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life). | from treatment to two years follow up |
| Quality of life outcomes | evaluation of quality of life of patients through the completion of questionnarie QLQ-AYA. Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life). | From treatment to two years follow up |
| Background |
| Li X, Ding R, Liu Z, Teixeira WMS, Ye J, Tian L, Li H, Guo S, Yao K, Ma Z, Liu Z. A predictive system comprising serum microRNAs and radiomics for residual retroperitoneal masses in metastatic nonseminomatous germ cell tumors. Cell Rep Med. 2024 Dec 17;5(12):101843. doi: 10.1016/j.xcrm.2024.101843. Epub 2024 Dec 12. |
| 36758194 | Background | Alsyouf M, Nappi L, Nichols C, Daneshmand S. Plasma Micro-RNA 371 Expression in Early-Stage Germ Cell Tumors: Are We Ready to Move Toward Biology-Based Decision Making? J Clin Oncol. 2023 May 10;41(14):2478-2482. doi: 10.1200/JCO.22.02002. Epub 2023 Feb 9. No abstract available. |
| 36254623 | Background | Konneh B, Lafin JT, Howard J, Gerald T, Amini A, Savelyeva A, Woldu SL, Lewis CM, Jia L, Margulis V, Coleman N, Scarpini C, Frazier AL, Murray MJ, Amatruda JF, Bagrodia A. Evaluation of miR-371a-3p to predict viable germ cell tumor in patients with pure seminoma receiving retroperitoneal lymph node dissection. Andrology. 2023 May;11(4):634-640. doi: 10.1111/andr.13317. Epub 2022 Nov 2. |
| 37568759 | Background | Nestler T, Schoch J, Belge G, Dieckmann KP. MicroRNA-371a-3p-The Novel Serum Biomarker in Testicular Germ Cell Tumors. Cancers (Basel). 2023 Aug 3;15(15):3944. doi: 10.3390/cancers15153944. |
| 37971743 | Background | Aziz Z, Wagner S, Agyekum A, Pumpalova YS, Prest M, Lim F, Rustgi S, Kastrinos F, Grady WM, Hur C. Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who Are Unscreened. JAMA Netw Open. 2023 Nov 1;6(11):e2343392. doi: 10.1001/jamanetworkopen.2023.43392. |
| 39165590 | Background | Tulik P, Maciak M, Tulik M. A dosimetric comparison of 3D-CRT, IMRT and IMAT treatment techniques - assessment from radiation protection point of view. Rep Pract Oncol Radiother. 2024 Mar 18;29(1):69-76. doi: 10.5603/rpor.99025. eCollection 2024. |
| 38398175 | Background | Pursley J, Remillard K, Depauw N, Lee G, Grassberger C, Paganetti H, Efstathiou JA, Kamran SC. Radiation Therapy for Stage IIA/B Seminoma: Modeling Secondary Cancer Risk for Protons and VMAT versus 3D Photons. Cancers (Basel). 2024 Feb 15;16(4):784. doi: 10.3390/cancers16040784. |
| 37408671 | Background | Maxwell R, Chang Y, Paul C, Vaughn DJ, Christodouleas JP. Cancer Control, Toxicity, and Secondary Malignancy Risks of Proton Radiation Therapy for Stage I-IIB Testicular Seminoma. Adv Radiat Oncol. 2023 May 2;8(5):101259. doi: 10.1016/j.adro.2023.101259. eCollection 2023 Sep-Oct. |
| 37683054 | Background | Ronde HS, Kronborg C, Hoyer M, Hansen J, Bak ME, Agergaard SN, Als AB, Agerbaek M, Lauritsen J, Meidahl Petersen P, Dysager L, Kallehauge JF. Dose comparison of robustly optimized intensity modulated proton therapy (IMPT) vs IMRT and VMAT photon plans for testicular seminoma. Acta Oncol. 2023 Oct;62(10):1222-1229. doi: 10.1080/0284186X.2023.2254925. Epub 2023 Sep 8. |
| 32426866 | Background | Xiang M, Chang DT, Pollom EL. Second cancer risk after primary cancer treatment with three-dimensional conformal, intensity-modulated, or proton beam radiation therapy. Cancer. 2020 Aug 1;126(15):3560-3568. doi: 10.1002/cncr.32938. Epub 2020 May 19. |
| 36228645 | Background | Giannatempo P, Nicolai N. What is the best way to treat patients with stage IIA or IIB seminoma? Lancet Oncol. 2022 Nov;23(11):1349-1350. doi: 10.1016/S1470-2045(22)00625-8. Epub 2022 Oct 10. No abstract available. |
| 12637477 | Background | Classen J, Schmidberger H, Meisner C, Souchon R, Sautter-Bihl ML, Sauer R, Weinknecht S, Kohrmann KU, Bamberg M. Radiotherapy for stages IIA/B testicular seminoma: final report of a prospective multicenter clinical trial. J Clin Oncol. 2003 Mar 15;21(6):1101-6. doi: 10.1200/JCO.2003.06.065. |