CompletedPhase 3

Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma

Argentina84 participantsStarted 2018-01-01

Plain-language summary

This protocol provides guidelines for the management of non-metastatic unilateral retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based upon the results of the Grupo de America Latina de Oncologia Pediatrica (GALOP) I study. Conservative therapy will be not protocolized.

Who can participate

Age range0 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological diagnosis of retinoblastoma confirmed at participating institutions * Ophthalmological diagnosis of unilateral retinoblastoma in patients undergoing conservative therapy. * No prior therapy for retinoblastoma * Lansky Performance Scale greater or equal to 50 * Normal organ function in those patients assigned for chemotherapy * Signed informed consent Exclusion Criteria: * Patients with unilateral retinoblastoma and germline mutations of the Rb1 gene or family history for retinoblastoma

What they're measuring

Rate of extraocular relapses

Timeframe: 3 years

Evaluation of number of patients experiencing acute, chronic and fatal toxicities

Timeframe: 5 years

Trial details

NCT IDNCT03475121

SponsorHospital JP Garrahan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-01-31

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