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AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy

NCT03308604 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-07-07

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Cyrus CHARGARI, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2022-07-31
Completion
2024-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308604 on ClinicalTrials.gov