Status:
RECRUITING
Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
Lead Sponsor:
Institut Curie
Collaborating Sponsors:
Fondation Rothschild Paris
Conditions:
Retinoblastoma
Eligibility:
All Genders
6-6 years
Phase:
PHASE2
PHASE3
Brief 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...
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...
Eligibility Criteria
Inclusion
- Overall study inclusion criteria:
- Newly diagnosed retinoblastoma (RB).
- Retinoblastoma with at least one eye eligible for conservative management.
- Patients likely to be compliant with the study requirements and visits, including late follow-up.
- Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer.
- Patients with no contraindication to the proposed treatments.
- Informed consent signed by parents or legal representative.
- French Social Security System coverage.
- Study 1 inclusion criteria:
- 1. Children aged from 6 months to 6 years. 9. Retinoblastoma in at least one eye, deemed manageable with IAC in one side and without IV chemotherapy:
- Unilateral Retinoblastoma classified as group B, C (if vitreous seeds \< 3 mm), D or E with no invasion of the anterior segment, and without massive tumor of more than 2/3 of the eye, eligible for conservative management, or
- Bilateral Retinoblastoma but with very unbalanced lesions between the two eyes: one eye group D or E without invasion of the anterior segment or massive tumor of more than 2/3 of the eye, eligible for IAC, and the other eye eligible for local treatment only (without IAC).
- Study 2 inclusion criteria:
- 2. Retinoblastoma eligible for conservative management although not manageable with IAC:
- Unilateral Retinoblastoma in children below 6 months of age, classified as Group A, B, C or D, with or without vitreous seeding, compatible with conservative management, or
- Bilateral Retinoblastoma classified as group A, B, C D, or E without invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye and eligible for conservative management.
Exclusion
- Overall study non-inclusion criteria:
- RB not eligible for conservative management :
- Extra-ocular extension of the disease, or
- Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye.
- Patient older than 6 years of age.
- Patients with another associated disease contra indicating systemic chemotherapy.
- Previously treated retinoblastoma by chemotherapy.
- Patients already treated for another malignant disease.
- Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patients whose parents have not accepted the treatment regimen after explanation of it.
- Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs.
- Inclusion in another experimental anti-cancer drug therapy.
- Study 1 non-inclusion criteria:
- Any contraindication or concomitant disease that would preclude the Study 1 treatment procedure and could delay treatment.
- These patients should be eligible for Study 2.
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2036
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04681417
Start Date
March 25 2021
End Date
January 20 2036
Last Update
November 28 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
La Reunion - Chr Felix Guyon
Saint-Denis, La Réunion, France, 97405
2
Amiens Chu
Amiens, France, 80054
3
Angers Chu
Angers, France, 49033
4
BESANCON CHU Hopital Jean Minjoz
Besançon, France, 25030