Status:
COMPLETED
Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma
Lead Sponsor:
Centre Leon Berard
Conditions:
Osteosarcoma
Eligibility:
All Genders
1-50 years
Phase:
PHASE2
Brief Summary
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 media...
Detailed Description
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 meta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00978471
Start Date
July 1 2009
End Date
October 29 2018
Last Update
May 17 2019
Active Locations (23)
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1
CHU Besançon- Hôpital Jean Minjoz
Besançon, France, 25000
2
Chu - Hopital Des Enfants Bordeaux
Bordeaux, France, 33000
3
CHU Dijon Le Bocage, Hôpital d'Enfants
Dijon, France, 21079
4
Chu Grenoble
Grenoble, France, 38045