Electronic Brachytherapy for the Treatment of NMSC (NCT01016899) | Clinical Trial Compass
CompletedNot Applicable
Electronic Brachytherapy for the Treatment of NMSC
United States187 participantsStarted 2009-08
Plain-language summary
The objective of this study is to record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the appearance of the treated area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin changes in patients treated for nonmelanoma skin cancer.
Who can participate
Age range
50 Years
Sex
ALL
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:
* Patient has signed the informed consent form
* Pathological diagnosis confirmed of squamous cell or basal cell carcinoma
* Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or Gx (Not assessed in report)
* Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter)
* One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.
Exclusion Criteria:
* T2 \> 4 cm and T3 and T4
* American Joint Committee Staging for NMSC Stages III and IV
* Histopathologic Grade 3 (poorly differentiated) or higher grade
* Target area is adjacent to a burn scar
* Target area is on the lip
* Patient \< 50 years of age
* Any prior definitive surgical resection of the cancer
* Perineural invasion
* Lesion depth \> 5mm on clinical assessment or as assessed by ultrasound or CT.
* Patient is pregnant (pregnancy test required if standard of care).
* Target area is prone to trauma.
* Target area with compromised lymphatic or vascular drainage.
* Participation in another investigational device or drug study concurrently.
* Patient has undergone prior radiation therapy to this specific anatomic location.
* Patient is receiving pharmacologic agent(s) at or around the time of the Radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study.
* Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks after radiat…
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
1
Local recurrence of NMSC
Timeframe: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.