An Open-Label, Single Arm, Feasibility And Safety Phase I Study With Nbtxr3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With Soft Tissue Sarcoma Of The Extremity
Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive
external beam radiotherapy starting on day 2 up to completion of 5 weeks, 5 days a week of
treatment (50Gy, 2Gy/fraction). Then, all patients will undergo surgical resection of the
tumor 5 weeks later and will be followed for wound healing and toxicity assessment. A visit
of end of treatment will take place approximately 3-4 weeks after surgery. Patients will be
followed for evaluation of their disease status and adverse events every 8 weeks until the
end of study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of the feasibility of the intratumor injection of NBTXR3
- 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
6 months
Yes
Sylvie Bonvalot, MD-PhD
Principal Investigator
Head of Surgery Division
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
NBTXR3-101
NCT01433068
October 2011
May 2014
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