Spots Global Cancer Trial Database for AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy
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Trial Identification
Brief Title: AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy
Official Title: Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer
Study ID: NCT03308604
Conditions
Study Description
Brief Summary: This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method. Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre Hospitalier Lyon Sud, Pierre-Bénite, Rhône, France
Gustave Roussy, Villejuif, Val De Marne, France
Contact Details
Name: Cyrus CHARGARI, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR
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