Osteosarcoma Clinical Trial
— OSII-TTPOfficial title:
Efficacy and Tolerance Adjuvant High-Dose Thiotepa With Peripheral Stem Cell Rescue Associated With Conventional Chemotherapy in Children and Adults With Relapsed Osteosarcoma
Verified date | August 2018 |
Source | Centre Leon Berard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | October 29, 2018 |
Est. primary completion date | October 29, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 50 Years |
Eligibility |
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 ßHCG 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Besançon- Hôpital Jean Minjoz | Besancon | |
France | Chu - Hopital Des Enfants Bordeaux | Bordeaux | |
France | CHU Dijon Le Bocage, Hôpital d'Enfants | Dijon | |
France | Chu Grenoble | Grenoble | |
France | Centre Oscar Lambret | Lille | |
France | Centre Léon Bérard - Institut d'Hémato-Oncologie Pediatrique | LYON Cedex 08 | |
France | Hôpital des Enfants de la Timone | Marseille | |
France | Institut Paoli Calmettes | Marseille | |
France | Chu Nantes - Hopital Meres Et Enfants | Nantes | |
France | Centre Antoine Lacassagne | Nice | |
France | CHU Nice, Hôpital L'Archet 2 | Nice | |
France | Hopital D'Enfants Armand Trousseau | Paris | |
France | Institut Curie | Paris | |
France | CHU Poitiers, site de la Milétrie | Poitiers | |
France | CHU RENNES - Hôpital Sud | Rennes | |
France | CHU de SAINT-ETIENNE, Hôpital Nord | Saint Priest en Jarez | |
France | Chu La Reunion | Saint-denis | |
France | Institut de Cancérologie de l'Ouest - René Gauducheau | Saint-herblain | |
France | Institut Lucien Neurwith | Saint-Priest-en -Jarez | |
France | Hopital de Hautepierre | Strasbourg | |
France | Chu Toulouse - Hopital D'Enfants | Toulouse | |
France | Chu Nancy - Hopital D'Enfants | Vandoeuvre Les Nancy | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
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* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate the overall survival rate | 24 months | ||
Secondary | Estimate overall survival after relapse diagnosis | 24 months | ||
Secondary | Estimate the survival free progression after randomization | 24 months | ||
Secondary | Evaluate the tolerance profile of experimental treatment (hematologic toxicity) | every 3 weeks | ||
Secondary | Estimate the rate of tumor response to treatment as assessed by conventional CT-scan | at inclusion, day 14-day 21 after the 2nd chemotherapy cycle, before randomization, day 14-day 21 after the 4th chemotherapy cycle, after thiotepa cure and 8 weeks after the end of treatment | ||
Secondary | Estimate histological response to treatment on surgical tumor samples | If surgery is applicable, a few weeks after thiotepa cure (12 to 17 weeks after inclusion) | ||
Secondary | Study of biological and genomic properties and analysis of angiogenic markers correlated with relapse (optional) | At inclusion,at surgery , and at the end of treatment |
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