Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02379845 | NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall | PHASE2 | COMPLETED | 180 | — | — | Mar 3, 2015 | Sep 20, 2020 | Apr 6, 2021 | 42 | Australia, Belgium +11 |
| NCT01433068 | NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity | PHASE1 | COMPLETED | 22 | — | — | Oct 1, 2011 | Feb 1, 2015 | Oct 6, 2020 | 2 | France |
To compare antitumor activity in terms of Pathological complete response rate (pCRR) of intratumor injection of NBTXR3 activated by external beam radiation therapy (EBRT), versus EBRT alone
\- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall
\- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | NBTXR3 + Radiotherapy |
| Arm B | ACTIVE_COMPARATOR | Radiotherapy alone |
| NBTXR3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NBTXR3 | DEVICE | One intratumor implantation by injection |
| Radiation therapy | DEVICE | 5 weeks/50 Gy (5 x 2 Gy by week) |
Inclusion Criteria: * Age: 18 years and older * Locally Advanced Soft Tissue Sarcoma of the Extremity and Trunk Wall * All grades * Candidate to radiotherapy + surgery (ESMO guideline 2014) i.e. tumor must not have involvement of bone and / or vessel and or nerve : * Primary tumor or, * Relaps...