Neoplasms

Eye Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Retinoblastoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Carboplatin

Etoposide

Cyclophosphamide

Vincristine

Etoposide phosphate

Thiotepa

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

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.

* Orbital irradiation
* 3 cycles of two different types of alternating chemotherapy courses (id 6 courses) :

  * Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection.
  * Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d)
  * Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide.
* High dose chemotherapy :

  * Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d)
  * Peripheral bood stem cell transplantation.

Observation

100 mg/m²/d, IV (in the vein) from D1 to D5.

45 Grays (Standard or external beam radiotherapy).

Orbital irradiation

15 mg, intrathecal Thiotepa injection at D1.

Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.

Cytapheresis

Peripheral bood stem cell transplantation

Isabelle AERTS, MD

Yves REGUERRE, MD

Camille KHANFAR, MD

Isabelle PELLIER, MD

Véronique LAITHIER, MD

Céline BOUYN-ICHER, MD

Liana-Sthéphania CARAUSU, MD

Damien BODET, MD

Justyna KANOLD

Claire BRIANDET, MD

Anne PAGNIER, MD

Hélène SUDOUR-BONNANGE, MD

Christophe PIGUET, MD

Benoit DUMONT, MD

Carole COZE, MD

Nicolas SIRVENT, MD

Estelle THEBAUD, MD

Maryline DUPUY-POIREE

Frédéric MILLOT, MD

Claire PLUCHART, MD

Chloé PUISEUX, MD

Pascale SCHNEIDER, MD

Jean-Louis STEPHAN, MD

Natacha ENTZ WERLE, MD

Anne-Isabelle BERTOZZI-SALAMON, MD

Pascale BLOUIN, MD

Ludovic MANSUY, MD

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

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 .

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

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Number of participants with treatment-related Adverse Events as assessed by CTCAE v3.0.

Number of patient in each histopathological risk group

Tumor genomic characterization in order to provide some new prognosis factors and better understanding of tumorigenesis by using of NGS (Next Generation Sequencing) techniques

Number of extra ocular extension detected by MRI

Institut Curie

Skin and Connective Tissue Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

4 courses of conventional chemotherapy followed by high-dose Thiotepa with peripheral stem cell rescue. Surgical resection of all tumor masses will be performed as soon as possible.

4 courses of conventional chemotherapy. Surgical resection of all tumor masses will be performed as soon as possible.

Thiotepa 8-12mg/m²/day/injection Total dose for one cure:15-50mg.

Perrine MAREC-BÉRARD, Dr

Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic.

Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months.

Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.

According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.

At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.

Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.

These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse.

Despite the absence of tumor registry, approximately 150 new cases of osteosarcoma are reported each year in France (100 cases per year in children and 50 cases in adults), of which 15 to 20% are metastatic. The standardized impact rate in the world population is estimated at 3 per million inhabitants per year.

Further to the initial standard care, about 45% of the patients relapse within a median interval of 20 months (range 3 months - 10 years).

Results of the OS94 study and of the investigation performed within the CRLCC indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.

Results of the five major published series indicate that the 5-year overall survival rate of patients in first relapse is between 23 and 28%, with a median post-relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.

At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.

Some recommendations have been given in the OS94 protocol, but they are generally not followed or they are implemented in a heterogeneous manner.

Thiotepa (N N' N'' triethylenethiophosphoramide), an alkylating agent of the chemical family of ethylene-imines, is known for its antitumor effect in a number of malignant tumors.

Its efficacy in osteosarcoma has been reported in the literature. A retrospective study of the SFCE (French Society for Childhood Cancer, results not yet published) in 45 patients presenting with refractory osteosarcoma or relapse has shown a radiological reaction rate of 30%.

Moreover, a preliminary investigation performed by the CLB in 2007 within the framework of the SFCE study explored all relapse cases diagnosed between the beginning of 2004 and the end of 2006. Results showed that about 35% of the patients with osteosarcoma relapses are treated with high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.

Altogether, these results led the SFCE osteosarcoma group to propose the evaluation of the efficacy and tolerance of this high-dose thiotepa chemotherapy within a clinical trial and to include the drug in the standard care of osteosarcoma in relapse.

Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma

Efficacy and Tolerance Adjuvant High-Dose Thiotepa With Peripheral Stem Cell Rescue Associated With Conventional Chemotherapy in Children and Adults With Relapsed Osteosarcoma

Centre Leon Berard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)	NCT02870907	Retinoblastoma	Observation Etoposide Vincristine Orbital irradia... Carboplatin Vincristine Cyclophosphamid... Carboplatin Etoposide Carboplatin Thiotepa Vincristine Cyclophosphamid... Cytapheresis Carboplatin Etoposide Thiotepa Peripheral bood...	2 Months - 10 Years	Institut Curie
Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma	NCT00978471	Osteosarcoma	Thiotepa	1 Year - 50 Years	Centre Leon Berard

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