Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy… (NCT02336763) | Clinical Trial Compass
TerminatedNot Applicable
Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases
Stopped: Closed due to lack of accrual
United States2 participantsStarted 2014-10
Plain-language summary
This clinical trial studies giving radiation therapy to the liver in patients with uveal (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2 and therefore more likely to have their disease spread from the eye to the liver. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to the liver may reduce the development of tumors in the liver and the overall risk of disease recurrence.
Who can participate
Age range
18 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:
* Histologically confirmed uveal melanoma
* Monosomy 3 status (by fluorescent in situ hybridization \[FISH\] or multiplex ligation-dependent probe amplification \[MLPA\]) or DecisionDx class 2
* Tumor thickness \> 3.0 mm
* Has received definitive treatment of uveal melanoma with brachytherapy, proton therapy, stereotactic radiosurgery, or enucleation
* Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG)
* Total bilirubin \< 1.5 mg/dl
* Aspartate transaminase (AST) up to two times normal limit
* Alanine transaminase (ALT) up to two times normal limit
* Creatinine \< 2.0 mg/dl
* Functional left kidney based on computed tomography (CT) imaging
* Positron emission tomography (PET)/CT demonstrating no evidence of metastatic disease
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use contraception for the duration of radiation therapy (approximately 3 weeks)
* Understands the trial and procedures and is willing and able to sign the Informed Consent Form
Exclusion Criteria:
* Previous malignancy, other than localized cutaneous squamous cell carcinoma or basal cell carcinoma
* History of prior irradiation to the thorax or abdomen
* Inadequate hepatic or kidney function (as specified above)
* Active peptic ulcer disease
* Upper gastrointestinal bleeding
* Pregnant women or women that refuse to use contraception throughout the entire stu…
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.