Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
This research is divided into two parts, both exploring new and better ways to treat retinoblastoma, a type of eye cancer that affects young children. The main aim is to improve how we manage the disease and help children keep their eyesight. One part of the study compares giving chemotherapy directly into an artery near the eye (intra-arterial chemotherapy) using one or two different medicines, alongside other eye treatments. The other part looks at standard treatments like chemotherapy given through a vein or local eye treatments, and focuses on how well children’s vision turns out afterwards. This study is for children aged 6 months to 6 years with newly diagnosed retinoblastoma.
Överblick
Vad handlar denna studie om?
This study is investigating new strategies to treat retinoblastoma, a type of cancer that starts in the retina, which is the light-sensing part of the eye. This condition most often affects young children. The main goal of this research is to find the most effective treatment approaches that can save the child's eye and help them keep their vision as much as possible.
The study is split into two main parts. In the first part, researchers are comparing two ways of giving chemotherapy directly into an artery that leads to the eye. This is called Intra-Arterial Chemotherapy (IAC). One group of children will receive a medicine called melphalan, and another group will receive melphalan plus another medicine called topotecan. Both groups will also get other local eye treatments. The aim here is to see which combination is better at controlling the cancer in the eye.
The second part of the study focuses on measuring how well children can see after they have received standard treatments for retinoblastoma. These standard treatments might include chemotherapy given through a vein (IV chemotherapy) along with local eye treatments like thermotherapy (using heat), cryotherapy (using cold), or special plaques containing Iodine-125. Some children in this group might receive only local eye treatments without IV chemotherapy. By carefully checking their vision, the researchers hope to understand which treatments lead to the best long-term eyesight outcomes.
Viktiga punkter
- This study explores new ways to treat retinoblastoma, a childhood eye cancer.
- It aims to improve eye-saving treatments and vision outcomes for children.
- Different types of chemotherapy and local eye treatments are being evaluated.
- There are two main parts of the study, looking at different treatment approaches.
- The study is for children aged 6 months to 6 years with new retinoblastoma diagnoses.
- Your child's eligibility depends on their specific cancer type and age.
Vem kan vara berättigad?
This study is looking for children aged between 6 months and 6 years who have recently been diagnosed with retinoblastoma. The cancer must be in at least one eye and be suitable for treatments that aim to save the eye rather than remove it. It's important that your child hasn't had chemotherapy or radiotherapy for cancer before.
For the first part of the study (comparing IAC treatments), children must have retinoblastoma in at least one eye that doctors believe can be treated with IAC. This includes certain types of retinoblastoma, including unilateral (one eye) or bilateral (both eyes) cases where one eye is suitable for IAC and the other can be managed with local treatments only.
For the second part of the study (looking at vision outcomes), children must have retinoblastoma that is suitable for eye-saving treatments, but not necessarily suitable for IAC. This might include unilateral retinoblastoma in very young children (under 6 months) or bilateral retinoblastoma of various types, as long as the cancer hasn't spread outside the eye or caused an overly large tumour that would prevent eye-saving treatments.
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.
- Is your child newly diagnosed with retinoblastoma?
- Is your child between 6 months and 6 years old?
- Has your child *not* received chemotherapy or radiation for cancer before?
- Has your child's doctor said the cancer might be treatable without removing the eye?
- Are you able to attend appointments for treatment and follow-up care?
- Does your child have French social security coverage? (This study is based in France.)
Vad innebär deltagande?
If your child takes part, the specific details will depend on which part of the study they are eligible for. Both studies involve treatment and follow-up appointments. The treatments mentioned include different types of chemotherapy, some given directly into an artery near the eye, some through a vein, and some injected directly into the eye. Local eye treatments such as thermotherapy (using heat), cryotherapy (using cold), or special radiation plaques might also be used.
You will need to attend regular visits for your child's treatment and check-ups. These visits will include eye examinations and tests to monitor the cancer and your child's vision. The researchers will also want to keep track of your child's health for a long time after the initial treatment. The total duration of participation, including long-term follow-up, will be discussed in detail by the study team, but it's important to be prepared for ongoing monitoring.
Potentiella risker och fördelar
Platser (28)
- La Reunion - Chr Felix GuyonVerifierat postnummerSaint-Denis, Frankrike· Rekrytering
- Amiens ChuVerifierat postnummerAmiens, Frankrike· Rekrytering
- Angers ChuVerifierat postnummerAngers, Frankrike· Rekrytering
- BESANCON CHU Hopital Jean MinjozVerifierat postnummerBesançon, France· Rekrytering
- Bordeaux ChuVerifierat postnummerBordeaux, Frankrike· Rekrytering
- BREST CHRU Hopital MorvanVerifierat postnummerBrest, Frankrike· Rekrytering
- CAEN CHUVerifierat postnummerCaen, Frankrike· Rekrytering
- CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP)Verifierat postnummerClermont-Ferrand, Frankrike· Rekrytering
- DIJON CHU Hopital François MitterandVerifierat postnummerDijon, Frankrike· Rekrytering
- Grenoble ChuVerifierat postnummerGrenoble, Frankrike· Rekrytering
- LILLE Centre Oscar LambretVerifierat postnummerLille, Frankrike· Rekrytering
- Limoges ChuVerifierat postnummerLimoges, Frankrike· Rekrytering
Vanliga frågor
What is retinoblastoma?
Retinoblastoma is a rare type of cancer that starts in the retina, the light-sensing tissue at the back of the eye, usually in young children.
What does 'conservative treatment' mean?
Conservative treatment means doctors are trying to treat the cancer while aiming to save the eye and ideally, your child's vision, rather than removing the eye.
What is Intra-Arterial Chemotherapy (IAC)?
IAC is a method where chemotherapy medicine is delivered directly into a blood vessel that supplies the eye, to target the cancer more precisely.
Will my child receive chemotherapy through the veins?
Some children in the study may receive chemotherapy through a vein (IV chemotherapy), while others might receive it directly into an artery in the eye or as a local injection into the eye, depending on their eligibility and the study part.
How will my child's vision be checked?
Your child's vision will be regularly assessed using methods typically used for children, following guidelines from the World Health Organization (WHO), to understand the impact of the treatments.
Hur du får reda på mer
Livia LUMBROSO LE ROUIC, MD
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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