NCT04681417

Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome

Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients: * Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

Detailed description

Primary objective of the studies: * Study 1: To evaluate the efficacy of IAC in term of local control of the disease in patients eligible for IAC (randomized phase II study); * Study 2: To assess the visual function, based on World Health Organization (WHO) criteria, in patients eligible for other conservative treatments (IV chemotherapy in association with local ophthalmologic trématent or local ophthalmological treatment without IV chemotherapy; this is a minimally invasive interventional study).

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
DRUG	Melphalan or Melphalan + Topotecan	IAC: 2-6 cycles every 1 month (number based on the local tumor evolution), performed using radio-guided catheterization and delivery at the ostium of the ophthalmic artery, in neuroradiology operating room, and under General Anesthesia (GA). IAC will be administered at the Fondation Rothschild Hospital in collaboration with the Interventional Neuroradiology team.
DRUG	etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy	2 to 6 cycles of combined etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy : thermotherapy and/or cryotherapy and/or iodine-125 plaques and/or intravitreal chemotherapy injections
DRUG	Carboplatin administered on Day 1	Chemothermotherapy : Intravenous injection by carboplatin
DEVICE	Thermotherapy (local treatment)	Thermotherapy after carboplatin administered on Day 1
DEVICE	Cryotherapy (local treatment)	Cryotherapy (local treatment)
DEVICE	Iodine-125 plaques (local treatment)	Iodine-125 plaques (local treatment)
DRUG	Intravitreal Melphalan chemotherapy injections (local treatment)	Intravitreal Melphalan chemotherapy injections (local treatment)

Timeline

• Start date: 2021-03-25
• Primary completion: 2035-01-20
• Completion: 2036-01-20
• First posted: 2020-12-23
• Last updated: 2025-11-28

Locations

28 sites across 1 country: France