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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
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
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
NOT_YET_RECRUITINGGustave Roussy
Villejuif, Val De Marne, France
RECRUITINGMaximum Tolerated Dose (MTD)
Time frame: Day 84 after inclusion
Recommended Phase 2 Dose (RP2D)
Time frame: Day 84 after inclusion
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15 Gy (maximal interval between EBRT and brachytherapy: 14 days).
Concomitant weekly intravenous cisplatin 40 mg/m2 will be delivered (total 5 cycles).