Status:
RECRUITING
Intrathecal Chemotherapy for Central Nervous System Metastasis in Retinoblastoma
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Collaborating Sponsors:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Children's Hospital of Fudan University
Conditions:
Retinoblastoma, Extraocular
Eligibility:
All Genders
Phase:
NA
Brief Summary
Retinoblastoma is the most common intraocular malignancy in infancy and childhood. The overall survival rate of retinoblastoma was reported to exceed 95% when children were early diagnosed with locali...
Eligibility Criteria
Inclusion
- The pathological diagnosis was retinoblastoma. According to the IRSs (International retinoblastoma staging system) staging system, the stage was IVB
- CSF tumor cells on cytology, or radiographic evidence of NM on MRI scans and histologic diagnosis of systemic malignancy needed
- KPS≥60%
- Adequate bone marrow and organ function
- The parents signed the informed consent and were willing to accept the treatment and follow-up.
Exclusion
- Eye diseases other than retinoblastoma
- The eyes were infected within 30 days before screening
- There was a history of surgery and / or unhealed wound within 1 month before enrollment .
- Those who have allergic reaction or allergic history to chemotherapeutic drugs.
- Infectious diseases requiring oral, intramuscular or intravenous administration.
- Patients with systemic immune diseases.
- Active disseminated intravascular coagulation.
- Abnormal coagulation function.
- Abnormal bone marrow and organ function.
- Uncontrollable clinical problems.
- The researchers believe that those who need to be excluded.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04903678
Start Date
May 1 2021
End Date
May 1 2030
Last Update
February 25 2025
Active Locations (1)
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1
Fudan Eye & ENT Hospital
Shanghai, China