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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2029
  • participants needed
    185
  • sponsor
    Institut Curie
Updated on 24 January 2021
renal function
stem cell transplantation
cyclophosphamide
vincristine
thiotepa
etoposide
carboplatin
unilateral retinoblastoma

Summary

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

Description

Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

  • Low risk group :
  • No optic nerve involvement.
  • Intra and prelaminar involvement
  • No choroidal involvement.
  • Minimal superficial choroidal involvement .
  • Intermediate risk group, 2 sub groups :
  • Sub group 1 :
  • Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement
  • Anterior segment involvement.
  • Intrascleral involvement.
  • Sub Group 2 :
  • Isolated massive choroidal involvement.
  • High risk group :
  • Invasion of the surgical margin of the optic nerve
  • and/or microscopic extrascleral involvement
  • Optic nerve meningeal sheat involvement .

Details
Condition Retinoblastoma
Treatment cyclophosphamide, etoposide, carboplatin, vincristine, Observation, thiotepa, Orbital irradiation, Cytapheresis, Cytapheresis, Peripheral bood stem cell transplantation
Clinical Study IdentifierNCT02870907
SponsorInstitut Curie
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines
Male or female 2 months and <10 years of age at the time of signing the informed consent form
Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation
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/m)
Patients affiliated to a Social Security Regimen or beneficiary of the same
No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types
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
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