Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Risk-Based Treatment for NRSTS in Young Patients
NCT00346164Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Sep 2014
- Countries
- 5
- Sponsor
- Children's Oncology Group
- Modality
- Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
- Conditions
- non-rhabdomyosarcoma soft tissue sarcoma (NRSTS)
01
Overview
Phase 3, open-label trial of ifosfamide and pegylated liposomal doxorubicin in non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) (4 arms), sponsored by Children's Oncology Group. Primary endpoint: Event Free Survival at 5 years. Started Feb 2007; status: completed.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Observation
Low risk patients, observation only
Adjuvant RT
Low risk patients with positive margins, adjuvant radiotherapy
Adjuvant ChemoRT
Intermediate/High risk resected, adjuvant chemotherapy and radiotherapy
Neoadjuvant ChemoRT
Intermediate/High risk unresected, neoadjuvant chemoRT followed by surgery and adjuvant chemo
03
Who it enrols
Patients under 30 years with newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma. Must have adequate organ function and no prior chemotherapy or radiotherapy.
04
Endpoints
Primary
Event Free Survival
Secondary
Toxicity Rate
Complete or Partial Response Rate
Percent Tumor Necrosis
Overall Survival
Incidence of Distant Metastasis
Beyond the preview
Go deeper on NCT00346164.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00346164.