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

• ClinicalTrials.gov Identifier: NCT02336763
• Recruitment Status: Terminated
• First Posted: January 13, 2015
• Results First Posted: March 11, 2016
• Last Update Posted: July 24, 2020
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

Tracking Information

• First Submitted Date: January 8, 2015
• First Posted Date: January 13, 2015
• Results First Submitted Date: February 12, 2016
• Results First Posted Date: March 11, 2016
• Last Update Posted Date: July 24, 2020
• Study Start Date: October 2014
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2016)

• Progression-free Survival [ Time Frame: Up to 5 years ]
• Reduction in Liver Metastasis [ Time Frame: Up to 5 years ]

Original Primary Outcome Measures (submitted: January 8, 2015)

• Progression-free survival [ Time Frame: Up to 5 years ]
• Reduction in liver metastasis [ Time Frame: Up to 5 years ]

Current Secondary Outcome Measures (submitted: February 12, 2016)

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

Original Secondary Outcome Measures (submitted: January 8, 2015)

• Frequency and severity of acute toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Within 3 months of study treatment ]
• Frequency and severity of late toxicity per NCI CTCAE version 4 [ Time Frame: More than 3 months after study treatment ]
• Overall survival [ Time Frame: Up to 5 years ]
• Distant failure rates [ Time Frame: 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.
• Disease-specific survival [ Time Frame: Up to 5 years ]
  Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: Prophylactic Hepatic Irradiation for 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• 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

Intervention

• Radiation: External Beam Radiation Therapy
  Undergo external beam radiation therapy
  Other Names:

  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT
• Other: Laboratory Biomarker Analysis
  Correlative studies

Study Arms

Experimental: 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.

Interventions:

• Radiation: External Beam Radiation Therapy
• Other: Laboratory Biomarker Analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 22, 2016): 2
• Original Estimated Enrollment (submitted: January 8, 2015): 50
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02336763
• Other Study ID Numbers: 14-000903; NCI-2014-02254 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); JCCCID466 ( Other Identifier: Jonsson Comprehensive Cancer Center )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jonsson Comprehensive Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Jonsson Comprehensive Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mitchell Kamrava; Jonsson Comprehensive Cancer Center

• PRS Account: Jonsson Comprehensive Cancer Center
• Verification Date: March 2016