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Gynecologic CancerPhase 1NANOCOLNCT03308604

AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy

A Phase 1 study testing Polysiloxane Gd-Chelates based nanoparticles (AGuIX), External beam radiotherapy (EBRT) and Uterovaginal brachytherapy in people with Gynecologic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
Polysiloxane Gd-Chelates based nanoparticles (AGuIX), External beam radiotherapy (EBRT) and Uterovaginal brachytherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesFrance
Study dates
17 May 2018to May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed cancer of the uterine cervix: squamous cell carcinoma or adenocarcinoma stage IB2-IVA according to the International Federation of Gynecology and Obstetrics classification, regardless of the pelvic lymph node stage. No evidence of metastatic disease. Primary staging should include: clinical examination, Pelvic MRI and 18-FDG PET. A coelioscopic para-aortic lymph node staging should be done in patients without para-aortic lymph node uptake to guide radiotherapy fields in the situation of pelvic lymph node metastases. If there is no pelvic lymph node metastases, para-aortic lymph node dissection is optional.
  • ECOG performance status 0-1.
  • Age between 18 - 70 years.
  • Neutrophils > 2000/mm^3.
  • Hemoglobin > 9 g/L after transfusion if necessary.
  • Platelets > 100,000/mm^3.
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  • Creatinine < 1.5 upper limit of normal or calculated creatinine clearance (Cockcroft-Gault Formula) ≥ 60 mL/min.
  • Liver function (GOT, GPT, alkaline phosphatase and bilirubin) < 1.5 upper limit of normal.
  • Cardiovascular: no clinically relevant cardiovascular disease, no congestive heart failure, no symptomatic coronary artery disease, no poorly controlled cardiac arrhythmia, no myocardial infarction within the past year.
  • Gastrointestinal: no active inflammatory bowel disease, no lack of physical integrity of the upper gastrointestinal tract, no malabsorption syndrome.
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment.
  • Proteinuria < 2 g/L (200mg/dL) and creatinine clearance ≥ 60 mL/min.
  • Signed informed consent after informing the patient.
  • Patient affiliated to a social security regimen or beneficiary of the same.

Who cannot join

  • Other histological types of cervical cancer than those listed in the inclusion criteria or stage IVB.
  • History of cancer other than basal cell carcinoma within five past years.
  • Prior treatment with radiotherapy, chemotherapy, targeted therapy or immune therapy for cervical cancer or for any cancer within five past years.
  • Prior pelvic radiotherapy or prior surgical treatment for cervical cancer (excluding diagnostic conisation).
  • Pregnancy or breastfeeding.
  • Obesity (Body Mass Index > 30).
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  • History of prior or current psychiatric illness.
  • Nephropathy, regardless of the grade.
  • Peripheral neuropathy ≥ grade 2.
  • Patients with pre-existing hearing impairments.
  • Active infection or other serious underlying pathology that could prevent the patient from receiving the treatment (especially liver or heart conditions).
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Inclusion in another clinical trial protocol with an experimental molecule (during this study or within 5 years prior to enrollment).
  • Unable to undergo the follow-up required by study for geographical, social or psychological reasons.
  • Contra-indication for Magnetic Resonance Imaging enhanced with gadolinium and/or any contra-indication to the use of cisplatin.
  • History of allergic reaction to cisplatin or other platinum containing compounds.
  • Concurrent administration of yellow fever vaccine.

Trial locations and contacts

2 sites in 1 country.

Cyrus CHARGARI, MD contact

+33 (0) 1 42 11 42 11 ext. 33 65

cyrus.chargari@gustaveroussy.fr

Matthieu TEXIER contact

+33 (0) 1 42 11 62 52

matthieu.texier@gustaveroussy.fr

France2 sites, 2 recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69310

    Ionela CARAIVAN, MD, +33 (0) 4 78 86 42 60, ionela.caraivan@chu-lyon.fr

    Ionela CARAIVAN, MD

    Not yet recruiting

  • Gustave Roussy

    Villejuif, Val De Marne, 94800

    Cyrus CHARGARI, MD, +33 (0) 1 42 11 42 11 ext. 33 65, cyrus.chargari@gustaveroussy.fr

    Matthieu TEXIER, +33 (0) 1 42 11 62 52, matthieu.texier@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

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

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).

Being tested
Polysiloxane Gd-Chelates based nanoparticles (AGuIX), External beam radiotherapy (EBRT), Uterovaginal brachytherapy, Chemotherapy (cisplatin)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polysiloxane Gd-Chelates based nanoparticles (AGuIX)Drug

    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.

  • External beam radiotherapy (EBRT)Radiation

    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

  • Uterovaginal brachytherapyRadiation

    15 Gy (maximal interval between EBRT and brachytherapy: 14 days).

  • Chemotherapy (cisplatin)Drug

    Concomitant weekly intravenous cisplatin 40 mg/m2 will be delivered (total 5 cycles).

Study groups in NCT03308604
Study groupRoleWhat they receive
Patients with locally advanced cervical cancerExperimentalNot described
Receives: Drug: Polysiloxane Gd-Chelates based nanoparticles (AGuIX); Radiation: External beam radiotherapy (EBRT); Radiation: Uterovaginal brachytherapy; Drug: Chemotherapy (cisplatin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    Measured: Day 84 after inclusion

  2. Recommended Phase 2 Dose (RP2D)

    Measured: Day 84 after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start17 May 2018
  3. Primary completionJul 2022 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308604
Sponsor's protocol ID
2016-005127-83
Other IDs
2016/2508, 2016
Acronym
NANOCOL
Status last verified
Jul 2021
First submitted
9 Oct 2017
Last updated
7 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Maury P, Mondini M, Chargari C, Darricau A, Shahin M, Ammari S, Bockel S, Genestie C, Wu TD, Lux F, Tillement O, Lacombe S, Deutsch E, Robert C, Porcel E. Clinical transfer of AGuIX(R)-based radiation treatments for locally advanced cervical cancer: MR quantification and in vitro insights in the NANOCOL clinical trial framework. Nanomedicine. 2023 Jun;50:102676. doi: 10.1016/j.nano.2023.102676. Epub 2023 Apr 20.

    PubMed 37084803

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Polysiloxane Gd-Chelates based nanoparticles (AGuIX), External beam radiotherapy (EBRT) and Uterovaginal brachytherapy in people with Gynecologic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cyrus CHARGARI, MD (+33 (0) 1 42 11 42 11 ext. 33 65, cyrus.chargari@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Day 84 after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03308604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.

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