Clinical trial · Interventional
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
Prophylactic Hepatic Irradiation for Uveal Melanoma
NCT02336763CI-TRIAL-00046158terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to lack of accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Iris Melanoma | Iris Melanoma | ONTOLOGY_EXACT | 0.98 |
| Medium/Large Size Posterior Uveal Melanoma | Medium/Large Size Posterior Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
| Stage IIB Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIA Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIB Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIC Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (external beam radiation therapy)
- description
- Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
- interventionNames
- Radiation: External Beam Radiation Therapy
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
- Up to 5 years
- measure
- Reduction in Liver Metastasis
- timeFrame
- Up to 5 years
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 study period * Currently receiving chemotherapy * Refuses to sign the informed consent form
References
Publications (0)
Data not yet available
No reference posted for this study.