This trial is evaluating whether CRADLE will improve 3 primary outcomes in patients with Leukocoria. Measurement will happen over the course of Day 1.
This trial requires 290 total participants across 3 different treatment groups
This trial involves 3 different treatments. CRADLE is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
"Retinoblastoma is an extremely rare tumor which, if treated appropriately with surgery, high doses of radiation, and chemotherapy, has a very low risk for spread. Consequently, in large US populations, retinoblastoma typically may be the most lethal form of cancer for females, but the very low risk of cancer-related death appears to be the greatest advantage to female patients, as seen in other countries." - Anonymous Online Contributor
"There is no evidence that retinoblastoma can be cured. On the contrary, in some cases (approximately one-third of childhood cases) the disease may become more severe despite the use of intensive initial chemotherapy, necessitating an even higher treatment intensity when the child is older (i.e. in adolescence, when the disease is more metastatic)." - Anonymous Online Contributor
"The retinoblastoma risk is affected by age, race, socioeconomic status, parental history, and other inherited factors. It has not yet been determined what causes retinoblastoma to occur by itself. It has not been established why some people develop retinoblastoma at only one time in their lifetime and more than one person in their family may develop retinoblastoma at different times. It is not known why some people who develop retinoblastoma are at a significant risk of developing and other people are more resistant to developing retinoblastoma. Many people with retinoblastoma have had one or more cancers that had cancer-causing genomic alterations." - Anonymous Online Contributor
"The most common treatment for retinoblastoma is enucleation, which is usually accompanied by radiotherapy and chemotherapy. External beam radiotherapy is commonly used to maximize the local destruction of cancer cells, while systemic therapy is used to minimize the effects and damage to normal cells. The type of chemotherapy agents used for metastatic retinoblastoma is also variable: doxorubicin, etoposide, and cisplatin are the commonly used agents. In addition, intraretinal and systemic chemotherapy treatments are used in combination with surgery, in case of progressive disease or in the presence of retinal vessel permeability." - Anonymous Online Contributor
"Children that have retinoblastomas are more likely to have one or more of the following symptoms: fever, vomiting, blood in stool, vomiting blood, stomach ache or pain, bleeding gums, lump or growth in the breast, stomach pains, lump in the breast, or sore throat. The commonest and most frightening symptom for children is a lump or growth in the breast. The most common symptom of retinoblastoma is a lump or growth in a socket of the eye." - Anonymous Online Contributor
"The common cancer with the highest number of cancer deaths worldwide is retinoblastoma, which is most lethal in developing countries. The primary cancer of children with the lowest number of cancer deaths worldwide is lung cancer. Retinoblastoma was the cause of around 5.3 of the 10,000 cancer-related deaths worldwide in 1999. Retinoblastoma is more common among children than adults, and this reflects the increasing life expectancy in the developing world. The survival rate in developing countries is much lower than in industrialized countries. There are variations across the globe. In the US, the five-year survival rate is nearly 90% while in Kenya, it is approximately 20%. Survival rates for other European countries are even lower." - Anonymous Online Contributor
"Although it remains the most common childhood cancer, the use of chemotherapy for retinoblastomas has not expanded in the last 3-6 years. The incidence of other cancers has declined due to improved prognosis of certain nonmalignant tumors." - Anonymous Online Contributor
"Since the advent of Cradle, a new approach has been discovered that appears to decrease the risk of death at a younger age in patients with retinoblastoma. Additional studies are warranted to determine the ultimate effect of Cradle on the mortality of patients with retinoblastoma, as well as the incidence of other malignancies." - Anonymous Online Contributor
"The RR in family members of patients with retinoblastoma is approximately 4-fold higher than expected, and similar to those seen in hereditary nonpolyposis [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer), Li-Fraumeni syndrome, hereditary breast-ovarian cancer syndrome, and hereditary renal cell cancer. These families warrant genetic diagnosis." - Anonymous Online Contributor
"The [CRB-4 CRT unit]] has been used clinically in the Netherlands and the United States; however, the use of CRB, as a whole, as part of multi-modality approach for treating CRB-4 expressing brain tumours has not been adopted outside the Netherlands. An important aspect of CRB use has been the observation and discussion of its risks and efficacy when used in a multi-modality setting. There was no apparent correlation between the CRB use and survival with the exception of the use of CRB in conjunction with surgical resection of the local disease." - Anonymous Online Contributor
"Data from a recent study provided more than 160 cases of retinoblastomas treated using CRT in a clinical setting. The mean age at diagnosis of these tumors was 2 years and 6 months. The most common form of CRT was the standard CRT (56%), followed by CRT plus radiotherapy (33%). The mean tumor size was > or =5 mm in size (63%). No statistically significant relationships were found between any of the study clinicobiologic factors tested and outcome. Because CRT had never been used in clinical trials with retinoblastoma before, it was considered reasonable to test for its impact on disease behavior and survival." - Anonymous Online Contributor
"There have been some advances. At first glance, newer treatments seem promising until more data is absorbed. Treatments have improved in the ability to save eyes with less risk. It is important to maintain your own well-being, but it is important to educate yourself and your family as well. Be proactive with research and update your latest treatments at your medical visits. Do not wait for the next treatment, there may not be one. Get informed to find your current treatments." - Anonymous Online Contributor