RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

Guangzhou Women and Children's Medical Center

Status: Unknown

Conditions: Ballon Technique; IAC; Selective Ophthalmic Artery Infusion; Retinoblastoma

Treatments: Device: SOAI; Device: Ballon Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03439397

GZWACMC20180112

Details and patient eligibility

About

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

Full 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.

Enrollment: 496 estimated patients

Sex: All

Ages: 1 month to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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496 participants in 2 patient groups

Ballon Technique group

Experimental group

Description:

Intervention：Ballon Technique

Treatment:

Device: Ballon Technique

SOAI group

Active Comparator group

Description:

Intervention：Selective Ophthalmic Artery Infusion

Treatment:

Device: SOAI