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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02336763

Enrollment

Registered

2015-01-13

Start date

2014-10-31

Completion date

2015-07-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Stage IIA Uveal Melanoma, Stage IIB Uveal Melanoma, Stage IIIA Uveal Melanoma, Stage IIIB Uveal Melanoma, Stage IIIC Uveal Melanoma

Brief 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.

Detailed description

PRIMARY OBJECTIVES: I. Progression free survival in patients treated with prophylactic hepatic irradiation. SECONDARY OBJECTIVES: I. Acute and late term toxicity and overall survival. OUTLINE: Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for 10 fractions over approximately 2 weeks. After completion of study treatment, patients are followed up every 6 months for 5 years.

Interventions

RADIATIONExternal Beam Radiation Therapy

Undergo external beam radiation therapy

OTHERLaboratory Biomarker Analysis

Correlative studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free Survival	Up to 5 years
Reduction in Liver Metastasis	Up to 5 years

Secondary

Measure	Time frame	Description
Overall Survival	Up to 5 years	—
Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4	Within 3 months of study treatment	—
Disease-specific Survival	Up to 5 years	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
Distant Failure Rates	Up to 5 years	Cumulative incidence approach (Kaplan-Meier \[K-M\] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4	More than 3 months after study treatment	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Treatment (External Beam Radiation Therapy) Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks. External Beam Radiation Therapy: Undergo external beam radiation therapy Laboratory Biomarker Analysis: Correlative studies	2
Total	2

Baseline characteristics

Characteristic	Treatment (External Beam Radiation Therapy)
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	2 Participants
Region of Enrollment United States	2 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 2
serious Total, serious adverse events	0 / 2

Outcome results

Primary

Progression-free Survival

Time frame: Up to 5 years

Population: Study terminated early no analysis conducted. Subjects would need to be followed for up to 5 years to answer this objective. Subject 1 was followed 5 months and subject 2 was followed 2 months. Therefore, data was not collected from any subject for this Outcome Measure.

Primary