Proton Radiotherapy for Stage I, IIA, and IIB Seminoma (NCT01557790) | Clinical Trial Compass
CompletedNot Applicable
Proton Radiotherapy for Stage I, IIA, and IIB Seminoma
United States5 participantsStarted 2012-03
Plain-language summary
Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of Defense. In the feasibility portion of the study patients will be evaluated to determine acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria
* Histological diagnosis; Histologically proven diagnosis of testicular seminoma; - Histologically confirmed seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic;
* Stage I disease; Any pT N0 M0 S0-3 (Appendix B) \[AJCC, 7th Ed.\] (72); Stage IIA or IIB disease;
* Any pT N1 M0 S0-3 (Appendix B) \[AJCC, 7th Ed.\] (72); Any pT N2 M0 S0-3 (Appendix B) \[AJCC, 7th Ed.\] (72); (at the discretion of the principal investigators, bulky stage IIB may be excluded from the study, according to National Comprehensive Cancer Center Guidelines. 2. Laboratory evaluations; Semen analysis (patients will not be excluded if they do not wish to have an analysis or their insurance denies the claim) Follice-stimulating hormone (prior to the start of radiation) Luteinizing Hormone (Prior to the start of radiation) Lactate Dehydrogenase (Prior to the start of radiation) Human Chorionic Gonadotropic (Prior to the start of radiation) Complete blood count (Prior to the start of radiation) Testosterone (prior to the start of radiation) 3. Appropriate stage for protocol entry, as per protocol section 3.2.1, , based upon the following minimum diagnostic workup: History and physical examination, including a complete list of current medications; Chest x-ray (PA and lateral views) or CT Chest (within 3 months of study registration); Abdominal/pelvic CT scan or Abd/pelvic MRI(within 3 months of study registration); Brain MRI if clinically indicated; Bo…