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Tests treatment safety and results for Retinoblastoma
Official title Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
ClinicalTrials.gov ID: NCT04681417
What this study is testing
What is Melphalan or Melphalan + Topotecan?
Melphalan or Melphalan + Topotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for retinoblastoma.
Also referred to as Alkeran, Topotecan Accord; Topotecan Hospira chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 6
You may be able to join if
- Overall study
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Overall study
- 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 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:
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Denis, La Réunion, France
- Amiens, France
- Angers, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Poitiers, France
- Reims, France
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Denis, La Réunion, France; Amiens, France; Angers, France; Besançon, France; Bordeaux, France; Brest, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.