Retinoblastoma Clinical Trial
— RETINO2018Official title:
Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018
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-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. - Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | January 20, 2036 |
Est. primary completion date | January 20, 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 6 Years |
Eligibility | Inclusion Criteria: Overall study inclusion criteria: 1. Newly diagnosed retinoblastoma (RB). 2. Retinoblastoma with at least one eye eligible for conservative management. 3. Patients likely to be compliant with the study requirements and visits, including late follow-up. 4. Patients not previously treated with chemotherapy or radiotherapy for this or any other cancer. 5. Patients with no contraindication to the proposed treatments. 6. Informed consent signed by parents or legal representative. 7. French Social Security System coverage. Study 1 inclusion criteria: 8.1. 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: 1. 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 2. 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: 8.2. Retinoblastoma eligible for conservative management although not manageable with IAC: 1. 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 2. 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 Criteria: Overall study non-inclusion criteria: 1. RB not eligible for conservative management : 1. Extra-ocular extension of the disease, or 2. Group E eyes with invasion of the anterior segment, and/or massive tumors of more than 2/3 of the eye. 2. Patient older than 6 years of age. 3. Patients with another associated disease contra indicating systemic chemotherapy. 4. Previously treated retinoblastoma by chemotherapy. 5. Patients already treated for another malignant disease. 6. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 7. Patients whose parents have not accepted the treatment regimen after explanation of it. 8. Contraindication to study drug mentioned in SmPC (Summary of Products Characteristics) of the study drugs. 9. Inclusion in another experimental anti-cancer drug therapy. Study 1 non-inclusion criteria: 10. 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. |
Country | Name | City | State |
---|---|---|---|
France | Amiens Chu | Amiens | |
France | Angers Chu | Angers | |
France | BESANCON CHU Hopital Jean Minjoz | Besancon | |
France | Bordeaux Chu | Bordeaux | |
France | BREST CHRU Hopital Morvan | Brest | |
France | CAEN CHU | Caen | |
France | CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP) | Clermont-Ferrand | |
France | DIJON CHU Hopital François Mitterand | Dijon | |
France | Grenoble Chu | Grenoble | |
France | LILLE Centre Oscar Lambret | Lille | |
France | Limoges Chu | Limoges | |
France | LYON Centre Léon Bérard | Lyon | |
France | Marseille Chu | Marseille | |
France | MONTPELLIER CHU Hopital Arnaud De Villeneuve | Montpellier | |
France | NANTES CHU Hopital Mere-Enfant | Nantes | |
France | NICE CHU Hopital Archet 2 | Nice | |
France | Institut Curie | Paris | |
France | PARIS Fondation Ophtalmologique Adolphe de Rothschild | Paris | |
France | Poitiers Chu | Poitiers | |
France | Reims Chu | Reims | |
France | Rennes Chu | Rennes | |
France | Rouen Chu | Rouen | |
France | Saint Etienne Chu | Saint Etienne | |
France | La Reunion - Chr Felix Guyon | Saint-Denis | La Réunion |
France | Strasbourg Chu | Strasbourg | |
France | Toulouse Chu | Toulouse | |
France | TOURS CHU Hopital Clocheville | Tours | |
France | Nancy Chu | Vandoeuvre Les Nancy |
Lead Sponsor | Collaborator |
---|---|
Institut Curie | Fondation Rothschild Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study 1: Rate of eye preservation | Rate of eye preservation in the 2 treatments' arms | 24 months after randomization | |
Primary | Visual function | Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (= 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension | when patient is 6 years old and at least 24 months of follow-up after study inclusion | |
Secondary | Ocular toxicity | Percentage of patients with at least one grade-3 or -4 toxicity (CTCAE v. 5.0) | Up to 24 months after inclusion in the study | |
Secondary | Systemic toxicity | Rate of specific grade 3-4 toxicity (CTCAE v. 5.0) | Up to 24 months after inclusion in the study | |
Secondary | Relapse | Percentage of patients with relapse within 24 months after inclusion, broken down into: Local relapse, Extra-ocular relapse | within 24 months after inclusion | |
Secondary | Second malignant tumor | Percentage of patients with second malignant tumor within 24 months after study inclusion | 24 months after study inclusion | |
Secondary | Additional assessment of visual function | Additional assessment of visual function at follow-up: Percentage of patients at each of the four levels of visual acuity according to WHO criteria | In the year patients turn 6 years of age and at least 24 months of treatment | |
Secondary | Retinal assessment | Optical Coherence Tomography (OCT) and Optical Coherence Tomography-Angiography (OCT-A) measures on retina | In the year patients turn 6 years of age and at least 24 months of treatment | |
Secondary | Integration at school | Rate of children able to attend the common primary school : without specific help or with the help of a dedicated person and/or with specific features to facilitate reading and writing | In the year patients turn 6 years of age and at least 24 months of treatment |
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