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study of giving chemotherapy once every 3 weeks instead of once every 4 weeks along with chemotherapy to spinal fluid in retinoblastoma

Pilot Study to Evaluate Dose Dense Vincristine, Etoposide, Carboplatin (VEC) Chemotherapy and Intrathecal Prophylaxis in IRSS Stage III Retinoblastoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002333
Enrollment
60
Registered
2012-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- INTERNATIONAL RETINOBLASTOMA STAGING SYSTEM (IRSS) STAGE III

Interventions

1-1.99 years: 20 mg
2-2.99 years: 30 mg
Intervention1: vincristine, etoposide, carboplatin (VEC) chemotherapy. Intrathecal chemotherapy with ARA-C, hydrocortisone and methotrexate: All patients will receive 3 cycles of neoadjuvant chemother
and older than 3 years: 40 mg. The dose of methotrexate will be as follows, 1 year: 6 mg
1-1.99 years: 8 mg
2-2.99 years: 10 mg and older than 3 years: 12 mg. The dose of hydrocortisone will be as follows, less than 1 year: 6 mg
1-1.99 years: 9 mg
2-2.99 years: 12 mg
older than 3 years: 15 mg. Intrathecal prophylaxis will be administered every 3 weeks along with VEC chemotherapy for a total of 12 doses. Control Intervention1: Historical controls: The patient outco

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Untreated consecutive IRSS stage III retinoblastoma patients will be included in the present study.

Exclusion criteria

Exclusion criteria: 1.Metastatic disease at baseline 2.Relapsed retinoblastoma in the same eye 3.Received previous chemotherapy for retinoblastoma 4.Upfront enucleation or exenteration of the involved eye 5.Does not consent to participate in the study

Design outcomes

Primary

MeasureTime frame
The event free survival and overall survival for study patients will be calculated 1. Event free survival (EFS): will be defined as the time from presentation to disease progression clinically or radiologically or death due to any cause. 2.Overall Survival (OS): will be defined as the time from presentation to death due to any cause. 3.Patients without an event or death were censored at time of last known follow-up. Timepoint: patients will be followed up every month while receiving treatment. They will be followed every 3 months after completion of treatment—

Secondary

MeasureTime frame
To evaluate patient compliance to treatmentTimepoint: atients will be followed up every month while receiving treatment. They will be followed every 3 months after completion of treatment—

Countries

India

Contacts

Public ContactSAMEER BAKHSHI

AIIMS

sambakh@hotmail.com9868398312

Outcome results

None listed

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