Iris MelanomaNCT02336763
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
A study testing External Beam Radiation Therapy and Laboratory Biomarker Analysis in people with Iris Melanoma and Medium/Large Size Posterior Uveal Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Stage IIA Uveal Melanoma
- What is being tested?
- External Beam Radiation Therapy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Prophylactic Hepatic Irradiation for Uveal Melanoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Progression free survival in patients treated with prophylactic hepatic irradiation.
SECONDARY OBJECTIVES:
- 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.
- 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
- Being tested
- External Beam Radiation Therapy, Laboratory Biomarker Analysis
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam RT
Undergo external beam radiation therapy
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (external beam radiation therapy) | Experimental | Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks. Receives: Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: Up to 5 years
Reduction in Liver Metastasis
Measured: Up to 5 years
Secondary outcomes (5)
Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Measured: Within 3 months of study treatment
Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4
Measured: More than 3 months after study treatment
Overall Survival
Measured: Up to 5 years
Distant Failure Rates
Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
Measured: Up to 5 years
Disease-specific Survival
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Closed due to lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iris MelanomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mitchell Kamrava, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336763
- Sponsor's protocol ID
- 14-000903
- Other IDs
- NCI-2014-02254, JCCCID466
- Status last verified
- Mar 2016
- First submitted
- 8 Jan 2015
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Hepatic Irradiation for Uveal Melanoma
- ClinicalTrials.gov ID
- NCT02336763
- Acronym / sponsor ID
- 14-000903
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to lack of accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 11 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Progression free survival in patients treated with prophylactic hepatic irradiation.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (external beam radiation therapy) | Experimental | Radiation: External Beam Radiation Therapy, Other: Laboratory Biomarker AnalysisPatients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam RTUndergo external beam radiation therapy | Radiation | Treatment (external beam radiation therapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (external beam radiation therapy) |
Primary outcome
Progression-free Survival
Time frame: Up to 5 years
Reduction in Liver Metastasis
Time frame: Up to 5 years
5 secondary outcomes
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
Disease-specific Survival
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Iris Melanoma
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
RecruitingObservational study
Observational Study of Iris Tumors
Iris Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Kamrava principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Beam Radiation Therapy and Laboratory Biomarker Analysis in people with Iris Melanoma and Medium/Large Size Posterior Uveal Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.