Retinoblastoma
Conditions
Interventions
Intra-arterial Group:Intra-arterial Chemotherapy
Combination Group:Intravenous chemotherapy + intra-arterial chemotherapy
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
0.3 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients clinically diagnosed with retinoblastoma. (2) According to the eighth edition of AJCC Cancer Staging System, the eye belonged to cT2N0M0 (cT2aN0M0, cT2bN0M0), and the eye did not receive any previous anti-tumor treatments, including intravenous chemotherapy, intra-arterial chemotherapy, intravitreal injection, laser, cryotherapy, and plaque radiotherapy, etc. (3) Older than 3 months, weighs over 5 kg. (4) Voluntarily participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with bilateral retinoblastoma at primary diagnosis. (2) Coagulation function: International Normalized ratio (INR) > 1.4; Activated partial thromboplastin time (APTT) > 34s. (3) Blood routine examination: Absolute value of peripheral blood neutrophils (ANC) 1.5 x ULN (normal upper limit 17.1µmol/L); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 x ULN (normal upper limit 40U/L); Albumin < 20 g/L. (5) Renal function: serum creatinine (Scr) was greater than the maximum reference concentration. (6) Participants in other clinical trials. (7) Any conditions that the researchers consider necessary to exclude from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free globe salvage rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| globe salvage rate;objective response rate;overall mortality;recurrence rate;Intracranial metastasis rate; | — |
Countries
China
Contacts
Public ContactFan Xianjun
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed