Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)
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| ClinicalTrials.gov Identifier: NCT02870907 |
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Recruitment Status :
Recruiting
First Posted : August 17, 2016
Last Update Posted : August 10, 2020
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Sponsor:
Institut Curie
Information provided by (Responsible Party):
Institut Curie
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Brief Summary:
Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Retinoblastoma | Other: Observation Drug: Etoposide Drug: Vincristine Radiation: Orbital irradiation Drug: Carboplatin Drug: Cyclophosphamide Drug: Thiotepa Procedure: Cytapheresis Procedure: Peripheral bood stem cell transplantation | Phase 2 |
Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
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Low risk group :
- No optic nerve involvement.
- Intra and prelaminar involvement
- No choroidal involvement.
- Minimal superficial choroidal involvement .
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Intermediate risk group, 2 sub groups :
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Sub group 1 :
- Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement
- Anterior segment involvement.
- Intrascleral involvement.
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Sub Group 2 :
- Isolated massive choroidal involvement.
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High risk group :
- Invasion of the surgical margin of the optic nerve
- and/or microscopic extrascleral involvement
- Optic nerve meningeal sheat involvement .
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 185 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated |
| Study Start Date : | March 2010 |
| Estimated Primary Completion Date : | March 2029 |
| Estimated Study Completion Date : | September 2029 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Retinoblastoma
| Arm | Intervention/treatment |
|---|---|
| Experimental: Low risk group |
Other: Observation
no post operative chemotherapy |
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Experimental: Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
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Drug: Etoposide
100 mg/m²/d, IV (in the vein) from D1 to D5. Drug: Carboplatin 160 mg/m²/d, IV from D1 to D5. Drug: Vincristine 1,5 mg/m²/d, IV at D22 and D26 Drug: Cyclophosphamide 300 mg/m²/d, IV from D22 to D26. |
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Experimental: Intermediate risk sub group 2
2 courses of Vincristin and Carboplatin
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Drug: Vincristine
1, 5 mg/m²/d, IV at D1. Drug: Carboplatin 560 mg/m²/d, IV at D1. |
Experimental: High risk group
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Radiation: Orbital irradiation
45 Grays (Standard or external beam radiotherapy). Drug: Etoposide 100 mg/m²/d, IV from D1 to D5 Drug: Carboplatin 160 mg/m²/d,IV from D1 to D5 Drug: Thiotepa 15 mg, intrathecal Thiotepa injection at D1. Drug: Vincristine 1,5 mg/m²/d), IV at D22 Drug: Cyclophosphamide 1000 mg/m²/d, IV from D22 à D24. Procedure: Cytapheresis Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid. Drug: Carboplatin AUC : 7/d, IV from D-8 to D-6. Drug: Etoposide 250 mg/m²/d, IV from D -5 to D-3. Drug: Thiotepa 300 mg/m²/d, IV from D-5 to D-3. Procedure: Peripheral bood stem cell transplantation at D0 |
Primary Outcome Measures :
- Rate of extra ocular relapses [ Time Frame: 5 years ]
Secondary Outcome Measures :
- Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary. [ Time Frame: 5 years ]Number of participants with treatment-related Adverse Events as assessed by CTCAE v3.0.
- Number of patient with secondary bilateralisation [ Time Frame: 5 years ]
- Evaluate the different histopathological risk factors frequency [ Time Frame: 5 years ]Number of patient in each histopathological risk group
- To determine tumors genomic [ Time Frame: at the inclusion ]Tumor genomic characterization in order to provide some new prognosis factors and better understanding of tumorigenesis by using of NGS (Next Generation Sequencing) techniques
- Evaluate sensitivity of MRI in detecting extra ocular extension [ Time Frame: At the inclusion ]Number of extra ocular extension detected by MRI
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| Ages Eligible for Study: | 2 Months to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines;
- Male or female ≥2 months and <10 years of age at the time of signing the informed consent form;
- Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation
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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).
- Patients affiliated to a Social Security Regimen or beneficiary of the same
- No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types
- Without medical cons-indication to study drugs.
Exclusion Criteria:
- Bilateral and/or familial or trilateral retinoblastoma.
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870907
Contacts
| Contact: Isabelle AERTS, MD | isabelle.aerts@curie.fr |
Locations
Show 27 study locations
Sponsors and Collaborators
Institut Curie
| Responsible Party: | Institut Curie |
| ClinicalTrials.gov Identifier: | NCT02870907 |
| Other Study ID Numbers: |
IC 2009-04 RB SFCE 09 |
| First Posted: | August 17, 2016 Key Record Dates |
| Last Update Posted: | August 10, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Institut Curie:
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primary enucleation retinoblastoma |
Additional relevant MeSH terms:
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Retinoblastoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Retinal Neoplasms Eye Neoplasms Neoplasms by Site Eye Diseases, Hereditary Eye Diseases Retinal Diseases Cyclophosphamide |
Thiotepa Carboplatin Etoposide Etoposide phosphate Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |