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Active, not recruiting Phase 2

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

NCT02870907 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2010-03-18
Last updated
2026-01-07

Condition(s) studied

Retinoblastoma

Investigational drug(s) / intervention(s)

ObservationEtoposide →Vincristine →Orbital irradiationCarboplatin →Vincristine →Cyclophosphamide →Carboplatin →Etoposide →Carboplatin →Thiotepa →Vincristine →Cyclophosphamide →CytapheresisCarboplatin →Etoposide →Thiotepa →Peripheral bood stem cell transplantation

Observation: no post operative chemotherapy

Etoposide: 100 mg/m²/d, IV (in the vein) from D1 to D5.

Vincristine: 1, 5 mg/m²/d, IV at D1.

Orbital irradiation: 45 Grays (Standard or external beam radiotherapy).

Carboplatin: 160 mg/m²/d, IV from D1 to D5.

Vincristine: 1,5 mg/m²/d, IV at D22 and D26

Cyclophosphamide: 300 mg/m²/d, IV from D22 to D26.

Carboplatin: 560 mg/m²/d, IV at D1.

Etoposide: 100 mg/m²/d, IV from D1 to D5

Carboplatin: 160 mg/m²/d,IV from D1 to D5

Thiotepa: 15 mg, intrathecal Thiotepa injection at D1.

Vincristine: 1,5 mg/m²/d), IV at D22

Cyclophosphamide: 1000 mg/m²/d, IV from D22 à D24.

Cytapheresis: Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.

Carboplatin: AUC : 7/d, IV from D-8 to D-6.

Etoposide: 250 mg/m²/d, IV from D -5 to D-3.

Thiotepa: 300 mg/m²/d, IV from D-5 to D-3.

Peripheral bood stem cell transplantation: at D0

Study summary

Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

Eligibility

Sex
ALL
Min age
2 Months
Max age
10 Years
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines; 2. Male or female ≥2 months and \<10 years of age at the time of signing the informed consent form; 3. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation 4. In case of post operative chemotherapy, patients must have adequate organ function: * Adequate hematopoietic function Neutrophils\>1.0x109/l, Platelets \>100 x 109/l. * Adequate hepatic function: grade II NCI CTC * Adequate renal function: serum creatinemia \<1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula * Audiometry \< Grade II de Brock. * Echocardiography normal in case of high dose cyclophosphamide chemotherapy (3 g/m²). 5. Patients affiliated to a Social Security Regimen or beneficiary of the same 6. No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types 7. Without medical cons-indication to study drugs. Exclusion Criteria: * Bilateral and/or familial or trilateral retinoblastoma. * Unilateral retinoblastoma with indication of primary chemotherapy before enucleation: * One or several surgical risk factors * Buphthalmia Exophthalmia. * Peri ocular inflammatory signs. * Extraocular extension : * Radiological retrolaminar extension (more than 3 mm behind the lamina cribrosa) and or meningeal sheat optic nerve extension. * Extrascleral extension * Lymp nodes extension * Unilateral retinoblastoma with possibility of conservative treatment: * Metastatic extension at diagnosis * One inclusion criteria non observed * Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Primary outcome measure(s)

  • Rate of extra ocular relapses — 5 years

Trial sites (27)

FacilityCityRegionStatus
Chr Felix Guyon Saint-Denis La Réunion
Hopital Nord Chu Amiens Amiens France
Chu Angers Angers France
Hopital Jean Minioz Besançon France
Chu R; Pellegrin Bordeaux France
Chu Morvan Brest France
CHU CAEN Caen France
Chu Estaing Clermont-Ferrand France
Chu Bocage Dijon France
Chu de Grenoble Grenoble France
Centre Oscar Lambret Lille France
Chu Limoges Limoges France
Centre Leon Berard Lyon France
Hopital D'Enfants La Timone Marseille France
Hopital Arnaud de Villeneuve Montpellier France
Chu Nantes Nantes France
Chu de Nice Nice France
Institut Curie Paris France
Chu de Poitiers Poitiers France
Chur de Reims Reims France
Chu de Rennes Rennes France
Chu de Rouen Rouen France
Chu Saint Etienne Saint-Etienne France
Hoptial Hautepierre Strasbourg France
Chu Toulouse Toulouse France
Chu Tours Tours France
Chu Nancy Vandœuvre-lès-Nancy France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02870907 on ClinicalTrials.gov ↗ ← All trials in France