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 range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Serious Adverse Events

Timeframe: 5 years

Trial details

NCT IDNCT01557790

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

Results submitted2019-10-16

View on ClinicalTrials.gov More Stage I, IIA and IIB Seminoma trials