Trial · NCT03712904
Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
NCT03712904, Phase 2, Terminated, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University; results first posted 2025-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma. Trials, record NCT03712904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03712904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
- NCT number
- NCT03712904
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Conditions
- Uveal Melanoma
- Interventions
- Stereotactic Body Radiation Therapy, Ziv-Aflibercept
- First posted
- 2018-10-19
- Last updated
- 2025-09-24
- Results first posted
- 2025-09-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | Up to approximately 6 months | Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept. |
| Secondary | Radiation Maculopathy Rate Defined as Ophthalmoscopic Detection of Macular Edema Perivascular Sheathing | At 2 years | Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval. |
| Secondary | Radiation Papillopathy Rate Defined as Ophthalmoscopic Detection of Peripapillary Encircling Nerve Fiber Layer Infarction | At 2 years | Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events | Up to approximately 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Radiation Maculopathy Rate Defined as Ophthalmoscopic Detection of Macular Edema Perivascular Sheathing | At 2 years | No participants were evaluable for this outcome. One participant withdrew consent, one experienced disease progression requiring eye removal prior to the assessment time point, and one died before reaching the two year mark. Subject who died was no longer a patient at the institution and their death was found through obituary search. | ||
| SECONDARY | Radiation Papillopathy Rate Defined as Ophthalmoscopic Detection of Peripapillary Encircling Nerve Fiber Layer Infarction | At 2 years | No participants were evaluable for this outcome. One participant withdrew consent, one experienced disease progression requiring eye removal prior to the assessment time point, and one died before reaching the two year mark. Subject who died was no longer a patient at the institution and their death was found through obituary search. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | Participants | ||
| Incidence of Adverse Events | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | |
| Overall Study | STARTED | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 2 | |
| Overall Study | COMPLETED | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | |
| Overall Study | COMPLETED | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | |
| Overall Study | NOT COMPLETED | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | |
| Overall Study | NOT COMPLETED | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 2 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic Rhinitis - Grade 1 | Respiratory, thoracic and mediastinal disorders | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 1 | 1 |
| other | Allergic Rhinitis - Grade 1 | Respiratory, thoracic and mediastinal disorders | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 2 | 0 |
| other | Atrial Fibrillation - Grade 3 | Cardiac disorders | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 1 | 1 |
| other | Atrial Fibrillation - Grade 3 | Cardiac disorders | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 2 | 0 |
| other | Bloating - Grade 1 | General disorders | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 1 | 0 |
| other | Bloating - Grade 1 | General disorders | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 2 | 1 |
| other | Blurred Vision - Grade 1 | Eye disorders | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 1 | 0 |
| other | Blurred Vision - Grade 1 | Eye disorders | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 2 | 2 | 2 |
| other | Cardiac Myopathy - Grade 1 | Cardiac disorders | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 1 | 1 |
| other | Cardiac Myopathy - Grade 1 | Cardiac disorders | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 2 | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 1 |
| Total, all-cause mortality | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 2 |
| Total, other adverse events | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 1 |
| Total, other adverse events | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 2 | 2 |
| Total, serious adverse events | A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | 1 |
| Total, serious adverse events | B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A. Stereotactic Body Radiation Therapy, Ziv-aflibercept vs B. Stereotactic Body Radiation Therapy, Ziv-aflibercept: Incidence of Adverse Events | Trial comparisons |
| A. Stereotactic Body Radiation Therapy, Ziv-aflibercept vs B. Stereotactic Body Radiation Therapy, Ziv-aflibercept: deaths from any cause | Trial comparisons |
| A. Stereotactic Body Radiation Therapy, Ziv-aflibercept vs B. Stereotactic Body Radiation Therapy, Ziv-aflibercept: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03712904
GET https://conductscience.org/api/trials/v1/NCT03712904/events?page=2