Osteosarcoma Clinical Trial
Official title:
Efficacy and Tolerance Adjuvant High-Dose Thiotepa With Peripheral Stem Cell Rescue Associated With Conventional Chemotherapy in Children and Adults With Relapsed Osteosarcoma
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.
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