Neoadjuvant Darovasertib in Primary Uveal Melanoma
This study, called OptimUM-10, is for people with early-stage uveal melanoma, a type of eye cancer that hasn't spread. We're testing a new medication called darovasertib. In some cases, patients will receive darovasertib before their standard treatment, which could be a special type of radiation (plaque brachytherapy) or surgery to remove the eye (enucleation). Other patients will have their standard treatment right away. We want to compare these approaches to see if starting with darovasertib can lead to better results. Everyone in the study will be followed for up to three years to check their vision and if the cancer comes back.
Överblick
Vad handlar denna studie om?
This research study is focused on a specific type of eye cancer called uveal melanoma that hasn't spread to other parts of the body. We're investigating whether a new drug, darovasertib, given before standard treatments, can make a difference for patients. Standard treatments for uveal melanoma include a special kind of radiation therapy (plaque brachytherapy) or, in some cases, surgery to remove the eye (enucleation). The study aims to see if using darovasertib first could improve how well these standard treatments work or lead to better long-term outcomes.
The study is divided into two groups, depending on the type of treatment usually recommended for a patient's uveal melanoma. In one group, we're comparing people who get darovasertib before plaque brachytherapy to those who receive plaque brachytherapy straight away. In the second group, we're comparing people who get darovasertib before their planned primary treatment (which could be plaque brachytherapy, another type of radiation called proton beam, or enucleation) to those who have enucleation straight away.
All patients will be carefully monitored for up to three years after their treatment. During this time, the research team will check their vision and look for any signs that the cancer has returned. This will help us understand the long-term effects of darovasertib and whether it could become a valuable new step in treating uveal melanoma.
Viktiga punkter
- This study evaluates a new drug (darovasertib) for early-stage eye cancer (uveal melanoma).
- It aims to see if darovasertib before standard treatment improves outcomes.
- Patients will be randomly assigned to different treatment groups.
- The study lasts up to three years, monitoring vision and cancer recurrence.
- It's for uveal melanoma that has not spread to other body parts.
Vem kan vara berättigad?
To join this study, you must have a type of eye cancer called uveal melanoma that hasn't spread to other parts of your body. You also need to be 18 years old or older. It's important that you are generally well enough to take part in the study, which means your body's organs are working properly, and you are able to sign a consent form and follow all the study instructions.
You would not be able to join this study if you have already had treatment for your uveal melanoma, or if there's evidence that your cancer has spread. Also, if there are other eye conditions that would make it difficult to properly check your vision, or if you have another type of cancer, you wouldn't be able to participate. Finally, if for some reason surgery to remove the eye is definitely needed, regardless of other treatments, then this study might not be suitable.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Do you have uveal melanoma that hasn't spread?
- Är du 18 år eller äldre?
- Are you generally well and able to participate in a study?
- Have you *not* had previous treatment for your uveal melanoma?
- Do you *not* have another active cancer?
Vad innebär deltagande?
If you decide to take part in this study, you would first sign an informed consent form. Depending on which group you're in, you might take the study medication, darovasertib, for a period of time before your main treatment (either radiation or surgery). During this time, and after your main treatment, you'll have regular hospital visits. These visits will involve various tests and check-ups to monitor your health, how the medication is working, and progress of your eye condition. We'll be checking things like your vision and looking for any changes in the cancer. You will be followed up for a total of three years to assess long-term outcomes. The study team will explain the full schedule of visits and assessments in detail if you are considering joining.
Potentiella risker och fördelar
Platser (94)
- Mayo Clinic Scottsdale - PPDSVerifierat postnummerScottsdale, USA· Rekrytering
- UCSD Moores Cancer CenterVerifierat postnummerLa Jolla, USA· Rekryterar inte ännu
- Jules Stein Eye InstituteVerifierat postnummerLos Angeles, USA· Rekryterar inte ännu
- USC Norris Omfattande CancercenterVerifierat postnummerLos Angeles, USA· Rekryterar inte ännu
- University of California Irvine Medical CenterVerifierat postnummerOrange, USA· Rekryterar inte ännu
- Stanford Comprehensive Cancer CenterVerifierat postnummerPalo Alto, USA· Rekrytering
- Kaiser Permanente-Riverside Medical CenterVerifierat postnummerRiverside, United States· Rekrytering
- UCSF Wayne and Gladys Valley Center for VisionVerifierat postnummerSan Francisco, USA· Rekryterar inte ännu
- University of Colorado HospitalVerifierat postnummerAurora, USA· Rekrytering
- The Melanoma and Skin Cancer InstituteVerifierat postnummerEnglewood, USA· Rekryterar inte ännu
- Mayo Clinic JacksonvilleVerifierat postnummerJacksonville, USA· Rekrytering
- USF Health Eye InstituteVerifierat postnummerTampa, USA· Rekryterar inte ännu
Vanliga frågor
What is uveal melanoma?
Uveal melanoma is a rare type of cancer that develops in the eye. This study is specifically for cases that have not spread to other parts of the body.
What is darovasertib?
Darovasertib is a new medication being tested to see if it can help treat uveal melanoma by affecting how the cancer cells grow.
What does 'neoadjuvant' mean?
'Neoadjuvant' means that the treatment (in this case, darovasertib) is given before the main, more definitive treatment like surgery or radiation.
Kommer jag definitivt att få det nya läkemedlet?
Not necessarily. This is a randomised study, meaning some participants will receive darovasertib before their standard treatment, while others will have their standard treatment straight away. Your doctor will explain which group you might be in.
Hur länge kommer jag att vara involverad i studien?
If you join the study, you will be followed for up to three years to monitor your health and the long-term effects of the treatments.
Hur du får reda på mer
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Diskussion
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