Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 2 Months - 10 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02870907

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Institut Curie

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Retinoblastoma
Additional Details

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 .

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hopital Nord Chu Amiens, Amiens, France

Status

Recruiting

Address

Hopital Nord Chu Amiens

Amiens, , 80054

Chu Angers, Angers, France

Status

Recruiting

Address

Chu Angers

Angers, , 49033

Hopital Jean Minioz, Besancon, France

Status

Recruiting

Address

Hopital Jean Minioz

Besancon, , 25030

Chu R; Pellegrin, Bordeaux, France

Status

Recruiting

Address

Chu R; Pellegrin

Bordeaux, , 33076

Chu Morvan, Brest, France

Status

Recruiting

Address

Chu Morvan

Brest, , 29609

CHU CAEN, Caen, France

Status

Recruiting

Address

CHU CAEN

Caen, , 14033

Chu Estaing, Clermont Ferrand, France

Status

Recruiting

Address

Chu Estaing

Clermont Ferrand, , 63003

Chu Bocage, Dijon, France

Status

Recruiting

Address

Chu Bocage

Dijon, , 21079

Chu de Grenoble, Grenoble, France

Status

Recruiting

Address

Chu de Grenoble

Grenoble, , 38043

Centre Oscar Lambret, Lille, France

Status

Recruiting

Address

Centre Oscar Lambret

Lille, , 59020

Chu Limoges, Limoges, France

Status

Recruiting

Address

Chu Limoges

Limoges, , 87042

Centre Leon Berard, Lyon, France

Status

Recruiting

Address

Centre Leon Berard

Lyon, , 69373

Hopital D'Enfants La Timone, Marseille, France

Status

Recruiting

Address

Hopital D'Enfants La Timone

Marseille, , 13385

Hopital Arnaud de Villeneuve, Montpellier, France

Status

Recruiting

Address

Hopital Arnaud de Villeneuve

Montpellier, , 34295

Chu Nantes, Nantes, France

Status

Recruiting

Address

Chu Nantes

Nantes, , 44093

Chu de Nice, Nice, France

Status

Recruiting

Address

Chu de Nice

Nice, , 06202

Institut Curie, Paris, France

Status

Recruiting

Address

Institut Curie

Paris, , 75005

Chu de Poitiers, Poitiers, France

Status

Recruiting

Address

Chu de Poitiers

Poitiers, , 86021

Chur de Reims, Reims, France

Status

Recruiting

Address

Chur de Reims

Reims, , 51100

Chu de Rennes, Rennes, France

Status

Recruiting

Address

Chu de Rennes

Rennes, , 35056

Chu de Rouen, Rouen, France

Status

Recruiting

Address

Chu de Rouen

Rouen, , 76031

Chr Felix Guyon, Saint Denis de La Reunion, France

Status

Recruiting

Address

Chr Felix Guyon

Saint Denis de La Reunion, , 97405

Chu Saint Etienne, Saint Etienne, France

Status

Recruiting

Address

Chu Saint Etienne

Saint Etienne, , 420555

Hoptial Hautepierre, Strasbourg, France

Status

Recruiting

Address

Hoptial Hautepierre

Strasbourg, , 67098

Chu Toulouse, Toulouse, France

Status

Recruiting

Address

Chu Toulouse

Toulouse, , 31026

Chu Tours, Tours, France

Status

Recruiting

Address

Chu Tours

Tours, , 37044

Chu Nancy, Vandoeuvre Les Nancy, France

Status

Recruiting

Address

Chu Nancy

Vandoeuvre Les Nancy, , 54500

The content provided by NBTS on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Terms, Conditions & Privacy