NCT03308604

AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy

Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
DRUG	Polysiloxane Gd-Chelates based nanoparticles (AGuIX)	Three intravenous injections of AGuIX will be delivered. The first injection of AGuIX will be delivered intravenously the 1st day and the 11th day of EBRT. The first injection will be preceded with an MRI (unenhanced T1 and T2 sequences) then followed with another MRI performed 4 hours later, to monitor tumor uptake. Irradiation will be performed after the second MRI. The second injection will be followed by an MRI 4 hours later. The third injection will be delivered intravenously the day of the brachytherapy procedure. Intravenous hydration will be performed during all brachytherapy courses to ensure AGuIX clearance. Up to three dose levels may be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2). The starting dose level will be 30mg/kg.
RADIATION	External beam radiotherapy (EBRT)	to the pelvis, with intensity modulated technique: 45 Gy in 5 weeks, with integrated boost to 55 - 57.5 Gy in case of macroscopic lymph node metastases
RADIATION	Uterovaginal brachytherapy	15 Gy (maximal interval between EBRT and brachytherapy: 14 days).
DRUG	Chemotherapy (cisplatin)	Concomitant weekly intravenous cisplatin 40 mg/m2 will be delivered (total 5 cycles).

Timeline

• Start date: 2018-05-17
• Primary completion: 2022-07-01
• Completion: 2024-05-01
• First posted: 2017-10-12
• Last updated: 2021-07-07

Locations

2 sites across 1 country: France