Status:
UNKNOWN
AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03308604
Start Date
May 17 2018
End Date
May 1 2024
Last Update
July 7 2021
Active Locations (2)
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1
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France, 69310
2
Gustave Roussy
Villejuif, Val De Marne, France, 94800