Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT03712904|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Radiation: Stereotactic Body Radiation Therapy Biological: Ziv-Aflibercept||Phase 2|
I. To assess the percentage of patients able to successfully complete their prescribed treatment of radiation and intravitreal ziv-aflibercept (aflibercept) injection (IAI) with an acceptable level of toxicity.
I. To assess for reduction in the incidence of 2-year rates of radiation maculopathy, radiation papillopathy, functional vision preservation, radiation glaucoma, and to assess 2-year local control and progression-free survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Trial of Stereotactic Radiotherapy (SRT) Followed by Intravitreal Aflibercept Injection for Patients With Ocular Melanoma|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||July 13, 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: A. Stereotactic body radiation therapy, ziv-aflibercept
Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Radiation: Stereotactic Body Radiation Therapy
Experimental: B. Stereotactic body radiation therapy, ziv-aflibercept
Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Incidence of grade 3 or higher toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 2 years ]Will be determined by patients who experience grade >= 3 toxicity related to stereotactic radiation therapy and/or intravitreal aflibercept. Will be tested using one-sided exact binomial test with alpha 0.05. The two arms will be combined for the primary analysis
- Radiation maculopathy rate defined as ophthalmoscopic detection of macular edema perivascular sheathing [ Time Frame: At 2 years ]Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.
- Radiation papillopathy rate defined as ophthalmoscopic detection of peripapillary encircling nerve fiber layer infarction [ Time Frame: At 2 years ]Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712904
|Contact: Wenyin Shi, MD, PhD||(215) firstname.lastname@example.org|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Wenyin Shi, MD, PhD 215-955-6702 email@example.com|
|Principal Investigator:||Wenyin Shi, MD, PhD||Sidney Kimmel Cancer Center at Thomas Jefferson University|