Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma
NCT ID: NCT00978471
Last Updated: 2019-05-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
44 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-07-31
Study Completion Date
2018-10-29
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Osteosarcoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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experimental arm thiotepa
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.
Group Type
EXPERIMENTAL
Thiotepa
Intervention Type
DRUG
Thiotepa 8-12mg/m²/day/injection Total dose for one cure:15-50mg.
Reference arm
4 courses of conventional chemotherapy. Surgical resection of all tumor masses will be performed as soon as possible.
Group Type
OTHER
Thiotepa
Intervention Type
DRUG
Thiotepa 8-12mg/m²/day/injection Total dose for one cure:15-50mg.
Interventions
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Thiotepa
Thiotepa 8-12mg/m²/day/injection Total dose for one cure:15-50mg.
Intervention Type
DRUG
Other Intervention Names
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N N'N'triethylenethiophosphosphoramide
Tepadina
Eligibility Criteria
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Inclusion Criteria
* Age \> 1 year and \< 50 years
* First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included.
* Indication for chemotherapy confirmed by a multidisciplinary committee.
* Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy.
* Lansky score ≥ 60%, or ECOG Performance Status ≤ 2
* ≥ 21-day interval after first-line chemotherapy
* Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows:
* blood: neutrophil count \> 1 G/L; platelets \>100 G/L
* renal: serum creatinine ≤ 1.5 x ULN depending on age; patients with serum creatinine values \> 1.5 x ULN are eligible if creatinine clearance is \> 70 mL/min/1.73 m²
* liver: total bilirubin \< 2 x ULN; ASAT and ALAT ≤ 5 x ULN
* cardiac: isotopic or echographic Left Ventricular Ejection Fraction \> 50 %.
* Signed written informed consent; for children, signed consent from the patient (depending on age) and from the parents or legal representative is mandatory
* Documented negative serum βHCG for female patients of childbearing age
* Affiliation with health insurance.
* First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included.
* Indication for chemotherapy confirmed by a multidisciplinary committee.
* Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy.
* Lansky score ≥ 60%, or ECOG Performance Status ≤ 2
* ≥ 21-day interval after first-line chemotherapy
* Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows:
* blood: neutrophil count \> 1 G/L; platelets \>100 G/L
* renal: serum creatinine ≤ 1.5 x ULN depending on age; patients with serum creatinine values \> 1.5 x ULN are eligible if creatinine clearance is \> 70 mL/min/1.73 m²
* liver: total bilirubin \< 2 x ULN; ASAT and ALAT ≤ 5 x ULN
* cardiac: isotopic or echographic Left Ventricular Ejection Fraction \> 50 %.
* Signed written informed consent; for children, signed consent from the patient (depending on age) and from the parents or legal representative is mandatory
* Documented negative serum βHCG for female patients of childbearing age
* Affiliation with health insurance.
Exclusion Criteria
* Patients with multiple relapses for whom surgical resection seems impossible, even after chemotherapy.
* Patients already treated with high-dose chemotherapy regimens
* Patients with a contra-indication to the treatment proposed
* Patients not eligible for leukapheresis
* Two-year follow-up impossible due to social, family, geographic or psychological reasons
* Patient included in another protocol of clinical research
* Pregnant or lactating women.
* Patients already treated with high-dose chemotherapy regimens
* Patients with a contra-indication to the treatment proposed
* Patients not eligible for leukapheresis
* Two-year follow-up impossible due to social, family, geographic or psychological reasons
* Patient included in another protocol of clinical research
* Pregnant or lactating women.
Minimum Eligible Age
1 Year
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Perrine MAREC-BÉRARD, Dr
Role: PRINCIPAL_INVESTIGATOR
Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP) - CLB
Locations
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CHU Besançon- Hôpital Jean Minjoz
Besançon, , France
Site Status
Chu - Hopital Des Enfants Bordeaux
Bordeaux, , France
Site Status
CHU Dijon Le Bocage, Hôpital d'Enfants
Dijon, , France
Site Status
Chu Grenoble
Grenoble, , France
Site Status
Centre Oscar Lambret
Lille, , France
Site Status
Centre Léon Bérard - Institut d'Hémato-Oncologie Pediatrique
Lyon, , France
Site Status
Institut Paoli Calmettes
Marseille, , France
Site Status
Hôpital des Enfants de la Timone
Marseille, , France
Site Status
Chu Nantes - Hopital Meres Et Enfants
Nantes, , France
Site Status
Centre Antoine Lacassagne
Nice, , France
Site Status
CHU Nice, Hôpital L'Archet 2
Nice, , France
Site Status
Institut Curie
Paris, , France
Site Status
Hopital D'Enfants Armand Trousseau
Paris, , France
Site Status
CHU Poitiers, site de la Milétrie
Poitiers, , France
Site Status
CHU RENNES - Hôpital Sud
Rennes, , France
Site Status
Chu La Reunion
Saint-Denis, , France
Site Status
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, , France
Site Status
CHU de SAINT-ETIENNE, Hôpital Nord
Saint-Priest-en-Jarez, , France
Site Status
Institut Lucien Neurwith
Saint-Priest-en-Jarez, , France
Site Status
Hopital de Hautepierre
Strasbourg, , France
Site Status
Chu Toulouse - Hopital D'Enfants
Toulouse, , France
Site Status
Chu Nancy - Hopital D'Enfants
Vandœuvre-lès-Nancy, , France
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
Countries
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France
References
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Sutow WW, Herson J, Perez C. Survival after metastasis in osteosarcoma. Natl Cancer Inst Monogr. 1981 Apr;(56):227-31.
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BACKGROUND
Gelderblom H, Jinks RC, Sydes M, Bramwell VH, van Glabbeke M, Grimer RJ, Hogendoorn PC, McTiernan A, Lewis IJ, Nooij MA, Taminiau AH, Whelan J; European Osteosarcoma Intergroup. Survival after recurrent osteosarcoma: data from 3 European Osteosarcoma Intergroup (EOI) randomized controlled trials. Eur J Cancer. 2011 Apr;47(6):895-902. doi: 10.1016/j.ejca.2010.11.036. Epub 2011 Jan 6.
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BACKGROUND
Leary SE, Wozniak AW, Billups CA, Wu J, McPherson V, Neel MD, Rao BN, Daw NC. Survival of pediatric patients after relapsed osteosarcoma: the St. Jude Children's Research Hospital experience. Cancer. 2013 Jul 15;119(14):2645-53. doi: 10.1002/cncr.28111. Epub 2013 Apr 26.
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BACKGROUND
Beron G, Euler A, winkley K.pulmonary metastase from osteogenic sarcoma: Complete resection and effective chemotherapy contributing to improved prognosis.Eur Paediatr Haematol Oncol 1985; 2:77-85
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BACKGROUND
Kaplan EL MP.Nonparametric estimation from incomplete observations.J Am Stat Assoc 1958
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-009899-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OSII-TTP
Identifier Type: -
Identifier Source: org_study_id
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