Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Wenyin Shi, MD, PhD||Sidney Kimmel Cancer Center at Thomas Jefferson University|