Clinical trial NCT03439397: RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Official title: RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinoblastoma
IAC
Selective Ophthalmic Artery Infusion
Ballon Technique
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 496
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Retinoblastoma is the most common intraocular tumor in children..IAC--Targeted Treatment for Intraocular Retinoblastoma,Is minimally invasive procedure that infuse chemotherapy select into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and reducing systemic toxicity compared with traditional intravenous treatment.: one is Ballon technique , another is selective ophthalmic artery infusion.This study evaluates the difference of Ballon technique and selective ophthalmic artery infusion effect in the treatment of retinoblastoma. Half of participants will receive, Ballon technique while the other half will receive selective ophthalmic artery infusion

Detailed description: Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Two alternative means can be used,The purpose of this study is to show that Ballon technique and SOAI delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment.

Eligibility criteria: Inclusion Criteria:

1. No age limit, no gender limit, monocular or binocular affected;
2. New diagnosed cases, without any previous treatment;
3. Clinical diagnosed as retinoblastoma, and in group C, D or E according to IIRC standard; Binocular affected with one eye enucleated;
4. Normal bone marrow function
5. Normal liver function
6. Normal kidney function
7. Normal coagulation function
8. To be willing to take part in the clinical trial and sign the informed consent form; 9. To be willing to have these tumor sites surgically removed and do the follow up accordingly.

Exclusion Criteria:

1. Diagnosis is not clear;
2. With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization);
3. With sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia;
4. Took part in other clinical study within 3 months;
5. Refuse to take part in this clinical study;
6. Is not willing to do the follow up accordingly or follow up less than 2 times.

Primary outcomes:
measure: Globe salvage rate (Eyes saved/Eyes treated)
timeFrame: Three years from intervention
Secondary outcomes:
measure: Visual pathway function
timeFrame: Three years from intervention
measure: complications
timeFrame: Three years from intervention
Other outcomes:
Locations:
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: huiming xia
role: STUDY_DIRECTOR
References: