Postoperative treatment for unilateral retinoblastoma after eye removal

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

This study is testing different treatments after eye removal in children with severe unilateral retinoblastoma to see if they can improve recovery and lower the chances of the cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (estimated)
• Ages: 2 Months to 10 Years
• Sex: All
• Sponsor: Institut Curie (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 27 sites (Saint-Denis, La Réunion and 26 other locations)
• Trial ID: NCT02870907 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of postoperative chemotherapy and/or radiotherapy for children with extensive unilateral retinoblastoma who have undergone primary enucleation. Treatment plans are tailored based on histopathological risk factors identified by the International Retinoblastoma Staging Working Group. Participants are categorized into low, intermediate, and high-risk groups, with specific interventions including observation, etoposide, vincristine, orbital irradiation, and carboplatin. The goal is to improve outcomes and reduce the risk of recurrence in these patients.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 months to 10 years diagnosed with non-familial extensive unilateral retinoblastoma who have undergone primary enucleation.

Not a fit: Patients who have received prior chemotherapy or radiotherapy before the trial will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates and quality of life for children with retinoblastoma.

How similar studies have performed: Previous studies have shown promising results with similar postoperative treatment approaches for retinoblastoma, indicating potential for success in this trial.

Eligibility criteria

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

Where this trial is running

Saint-Denis, La Réunion and 26 other locations

• Chr Felix Guyon — Saint-Denis, La Réunion, France (Recruiting)
• Hopital Nord Chu Amiens — Amiens, France (Recruiting)
• Chu Angers — Angers, France (Recruiting)
• Hopital Jean Minioz — Besancon, France (Recruiting)
• Chu R; Pellegrin — Bordeaux, France (Recruiting)
• Chu Morvan — Brest, France (Recruiting)
• Chu Caen — Caen, France (Recruiting)
• Chu Estaing — Clermont Ferrand, France (Recruiting)
• Chu Bocage — Dijon, France (Recruiting)
• Chu de Grenoble — Grenoble, France (Recruiting)
• Centre Oscar Lambret — Lille, France (Recruiting)
• Chu Limoges — Limoges, France (Recruiting)
• Centre Leon Berard — Lyon, France (Recruiting)
• Hopital D'Enfants La Timone — Marseille, France (Recruiting)
• Hopital Arnaud de Villeneuve — Montpellier, France (Recruiting)
• Chu Nantes — Nantes, France (Recruiting)
• Chu de Nice — Nice, France (Recruiting)
• Institut Curie — Paris, France (Recruiting)
• Chu de Poitiers — Poitiers, France (Recruiting)
• Chur de Reims — Reims, France (Recruiting)
• Chu de Rennes — Rennes, France (Recruiting)
• Chu de Rouen — Rouen, France (Recruiting)
• Chu Saint Etienne — Saint Etienne, France (Recruiting)
• Hoptial Hautepierre — Strasbourg, France (Recruiting)
• Chu Toulouse — Toulouse, France (Recruiting)
• Chu Tours — Tours, France (Recruiting)
• Chu Nancy — Vandoeuvre Les Nancy, France (Recruiting)

Study contacts

• Study coordinator: Isabelle AERTS, MD

Conditions Retinoblastoma; primary enucleation; retinoblastoma