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A multi-center, prospective, randomized study of sequential Intravenous chemotherapy combine with Intra-Arterial chemotherapy vs Intra-Arterial Chemotherapy for Retinoblastoma

A multi-center, prospective, randomized study of sequential Intravenous chemotherapy combine with Intra-Arterial chemotherapy vs Intra-Arterial Chemotherapy for Retinoblastoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007067
Enrollment
Unknown
Registered
2015-09-13
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinoblastoma

Interventions

sequential Intravenous chemotherapy combine with Intra-Arterial chemotherapy :sequential Intravenous chemotherapy combine with Intra-Arterial chemotherapy
Intra-Arterial chemotherapy : Intra-Arterial chemotherapy

Sponsors

GuangZhou Women Childrens Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 99 Years

Inclusion 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, in B2, C, D or E according to IIRC standard; Binocular affected with one eye enucleated (with no pathological high risks), the other can be bring in if it match the condition above; (Difference between B1 B2: B1 can be cured by local laser, B2 needs chemotherapy); 4. Normal bone marrow function: ANC >=750/uL; Plt >75,000/uL; Hb>=8.0 gm/dL; 5. Normal liver function: total bilirubin =2 g/dL; 6. Normal kidney function: Ccr) >=70ml/min/1.73 m2 or normal Scr according to age gender; 7. Normal coagulation function: INR<1.4; APTT<34s; 8. to be willing to take part in the clinical trial sign the informed consent form; 9. to be willing to have these tumor sites surgically removed do the follow accordingly.

Exclusion criteria

Exclusion criteria: 1. Diagnosis is not clear; 2. Diagnosis is clear, but cases belong to A, B1 or E with high risks.Gro E with high risks; 3. With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization); 4. With sever temic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases dyudia; 5. Took part in other clinical study within 3 months; 6. Refuse to take part in this clinical study; 7. Is not willing to do the follow accordingly or follow less than 2 times.

Design outcomes

Primary

MeasureTime frame
survival rate;eyeball ve rate;recurrence rate;cure rate;adverse event rate;

Countries

china

Contacts

Public ContactZhang Jing
fejr@foxmail.com+86 13826282846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026