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Multimodal Management of stage 2 and 3 extraocular retinoblastoma An Interventional pilot study

Multimodal Management of stage II and III extraocular retinoblastoma : An Interventional pilot study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066837
Enrollment
30
Registered
2024-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: C692- Malignant neoplasm of retina Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Multimodal management: 4 cycles of adjuvant Chemotherapy with Vincristine (1.5 mg/m2 on D0, D7, D14) , cyclophosphamide(1950 mg/m2 on D1, D2), Cisplatin (105 mg/m2 on D0) and Etoposide

Sponsors

Department of Pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Those fulfilling the criteria for IRSS stage II and III of extraocular retinoblastoma defined previously will be included in the study.

Exclusion criteria

Exclusion criteria: Pre-existing renal disease Pre-existing Hearing impairment Relapsed extraocular retinoblastoma

Design outcomes

Primary

MeasureTime frame
To estimate the Disease free survival (DFS) at 1 year after multimodal management in children less than 18 years diagnosed with stage II and III extraocular retinoblastomaTimepoint: 12 months after treatment completion

Secondary

MeasureTime frame
To study the adverse effects using CTCAE criteria in children less than 18 years diagnosed with stage II & III extraocular retinoblastoma To study the variability in interpretation of PET/CT & MRI in management of stage II & III extraocular retinoblastoma in children less than 18 years To evaluate ototoxicity associated with this regimen in children less than 18 years diagnosed with stage II & III extraocular retinoblastomaTimepoint: 1 year

Countries

India

Contacts

Public ContactShivani Deep Singh

All India Institute of Medical Sciences, New Delhi

drrachnaseth1967@gmail.com9971188687

Outcome results

None listed

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