Proton Radiotherapy for Stage I, IIA, and IIB Seminoma

Not Applicable

Completed

• Conditions: Stage I, IIA and IIB Seminoma
• Interventions: Radiation: Proton Radiation Therapy

• Registration Number: NCT01557790
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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).

Detailed Description

This is a Phase II study using proton radiation therapy in addition to their standard care in subjects who have Stage I, IIA, IIB Seminoma. Testicular cancer are the most common solid cancers among men aged 20 to 35. Each subject must be 18 years of age or older and have a histologically proven diagnosis of testicular cancer. In addition to a subject's routine exams and tests, they will be asked to complete a series of quality of life questionnaires before, during and after their treatment. All side effects/toxicities will be monitored and recorded. Patients will be followed for a minimum of 5 years.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2019-10-16
• Results First Submitted QC: 2019-11-04
• Results First Posted: 2019-11-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton RT	Proton Radiation Therapy	Subjects receive proton radiation for seminoma

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events	5 years

Trial Locations

Locations (2)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Massachusettes General Hospital; 🇺🇸 Boston, Massachusetts, United States