Treatment of Intraocular Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Clinical Study of Superselective Ophthalmic Artery Interventional Chemotherapy for Intraocular Retinoblastoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05028270
• Other study ID #: XH-21-06
• Status: Not yet recruiting
• Start date: June 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Chaohui Jin, Phd, MD
• Phone: +8613636694571
• Email: 13636694571[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares the effects of balloon technology and microcatheter technology on the eye protection rate of neuroblastoma

Description:

Retinoblastoma is the most common intraocular malignant tumor in childhood, with an incidence of about 1/15,000-20,000, accounting for 4% of all childhood cancers. All patients with bilateral reticuloblastoma and approximately 10%-15% of children with unilateral disease have germline mutations that can be passed on to their offspring.In developed countries, the survival rate is close to 98%. However, due to the limitations of health care in low-income countries, this proportion is much lower, about 40%. Before the 1990s, retinoblastoma was mainly treated with enucleation and external beam radiation therapy (EBRT). However, these methods are associated with many complications, including vision loss and serious side effects. At present, the first-line conservative treatment of retinoblastoma has changed from EBRT and enucleation to Intravenous chemotherapy (IVC) or intra-arterial chemotherapy (IAC), and it has been consolidated through focal treatment. There are two different surgical procedures for intra-arterial chemotherapy, namely balloon technique and microcatheter technique. Investigators observe their effects through a retrospective case-control study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: August 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

1. 1 year old <age = 18 years old;

2. After biopsy, histopathology and immunohistochemistry tests refer to the COG recommended neuroblastoma diagnostic criteria, pathological classification (INPC), and international neuroblastoma staging (INSS)

3. Patients who were diagnosed with RB for the first time or received chemotherapy in our hospital for the first time after diagnosis

4. ECOG scale (ECOG-PS) = 2;

Exclusion Criteria:

1. No antibiotics and no gastrointestinal surgery within 3 months.

2. Patients with autoimmune diseases;

3. Patients with immunodeficiency;

4. Patients who have been treated for relapsed/refractory diseases; relapsed NB is the appearance of new lesions at the primary site or other sites 4 weeks after the multidisciplinary comprehensive treatment reaches CR. Refractory NB is defined as induced by 2 to 4 courses of treatment The post-effect evaluation is progression disease (PD) during chemotherapy;

5. Multiple organ failure;

6. Uncontrolled infection and diarrhea

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Procedure:
• Balloon technology;Microcatheter technology
Describe each group's intervention in sufficient detail, including how and when to give the intervention Suspend or modify the criteria for interventions that have been assigned to the subject (such as changing the dose of the drug due to hazards or subject requirements or improvement/deterioration of the condition, etc.) Strategies to improve the compliance of intervention programs, and other measures to monitor compliance (such as the return of drug tablets, laboratory inspections, etc.) Related care and interventions allowed or prohibited during the trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall success rate	To evaluate the 1-year ocular salvage rate in the treatment of retinoblastoma [ Time Frame: 1 year ] 12-month ocular salvage rate: calculate the number and percentage of subjects who reach 12-month ocular salvage rate, and use the exact probability method to estimate 95% CI.	1 year
Primary	Second tumor rate	To evaluate the 1-year recurrence of the tumor.	1 year