Adults 10 to 65, any sex, with Metastatic Osteosarcoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Treated Participants With 6-month Progression Free SurvivalPrimary· 6 months post-intervention
Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.
Group
Value
95% CI
SmEDTMP/Autologous Stem Cell Infusion/RT
0
Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With ToxicitySecondary· Up to 48 months
Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.
Group
Value
95% CI
SmEDTMP/Autologous Stem Cell Infusion/RT
4
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 4 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
SmEDTMP/Autologous Stem Cell Infusion/RT
Serious: 3/4 (75%)
Deaths: 4/4
Serious adverse events (3 terms)
Reaction
System
SmEDTMP/Autologous Stem Ce…
Hospitalization
Respiratory, thoracic and mediastinal disorders
—
Hospitalization
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 29 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01886105.