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.
एक नजर में
यह अध्ययन किस बारे में है?
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.
मुख्य निष्कर्ष
- 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.
- रोगियों को विभिन्न उपचार समूहों में यादृच्छिक रूप से असाइन किया जाएगा।.
- 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.
कौन पात्र हो सकता है?
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.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- Do you have uveal melanoma that hasn't spread?
- क्या आप 18 वर्ष या उससे अधिक आयु के हैं?
- 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?
भागीदारी में क्या शामिल है?
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.
संभावित जोखिम और लाभ
स्थान (94)
- Mayo Clinic Scottsdale - PPDSसत्यापित पोस्टकोडस्कॉट्सडेल, संयुक्त राज्य अमेरिका· भर्ती
- UCSD Moores Cancer Centerसत्यापित पोस्टकोडला जोला, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- Jules Stein Eye Instituteसत्यापित पोस्टकोडलॉस एंजेलेस, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- यूएससी नॉरिस व्यापक कैंसर केंद्रसत्यापित पोस्टकोडलॉस एंजेलेस, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- कैलिफोर्निया विश्वविद्यालय इरविन मेडिकल सेंटरसत्यापित पोस्टकोडऑरेंज, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- Stanford Comprehensive Cancer Centerसत्यापित पोस्टकोडपैलो आल्टो, संयुक्त राज्य अमेरिका· भर्ती
- Kaiser Permanente-Riverside Medical Centerसत्यापित पोस्टकोडरिवरसाइड, संयुक्त राज्य अमेरिका· भर्ती
- UCSF Wayne and Gladys Valley Center for Visionसत्यापित पोस्टकोडसैन फ्रांसिस्को, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- University of Colorado Hospitalसत्यापित पोस्टकोडऑरोरा, संयुक्त राज्य अमेरिका· भर्ती
- The Melanoma and Skin Cancer Instituteसत्यापित पोस्टकोडएंगलवुड, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
- मेयो क्लिनिक जैक्सनविलसत्यापित पोस्टकोडजैक्सनविल, संयुक्त राज्य अमेरिका· भर्ती
- USF Health Eye Instituteसत्यापित पोस्टकोडटाम्पा, संयुक्त राज्य अमेरिका· अभी भर्ती नहीं हो रही है
सामान्य प्रश्न
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.
क्या मुझे निश्चित रूप से नई दवा मिलेगी?
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.
मैं इस अध्ययन में कितने समय तक शामिल रहूँगा?
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.
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