NBTXR3 and Radiation Therapy in Treating Patients With Locally Advanced SCC of the Oral Cavity or Oropharynx
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ClinicalTrials.gov Identifier: NCT01946867 |
Recruitment Status :
Active, not recruiting
First Posted : September 20, 2013
Last Update Posted : December 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Device: NBTXR3 activated by IMRT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | This study consists of two parts: Dose Escalation and Dose Expansion. This phase I is an open-label non-randomized, dose-escalation/dose expansion study of safety and tolerability evaluation of NBTXR3, administered as an intratumoral implantation by injection, activated by intensity modulated radiation therapy (IMRT), in patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Dose-Escalation/Dose Expansion Study Of NBTXR3 Activated By Intensity Modulated Radiation Therapy In Patients With Locally Advanced Squamous Cell Carcinoma Of The Oral Cavity Or Oropharynx |
Actual Study Start Date : | January 3, 2014 |
Estimated Primary Completion Date : | February 2023 |
Estimated Study Completion Date : | February 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: NBTXR3 IntraTumoral injection (IT)
Single intratumor injection
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Device: NBTXR3 activated by IMRT |
- Dose Escalation: Incidence of DLTs and determination of the Recommended Phase 2 Dose [ Time Frame: 12 months ]The incidence of early DLTs (early adverse effects related to NBTXR3, as an intratumor injection, activated by IMRT)
- Dose Escalation: Determination of the Recommended Phase 2 Dose [ Time Frame: 12 months ]The recommended Phase II dose (RD) of NBTXR3 administered as intratumor injection, activated by Intensity Modulated Radiation Therapy (IMRT)
- Dose Expansion: Overall Response Rate [ Time Frame: 12-24 months ]The Objective Response Rate (ORR) of the primary tumor, by imaging according to RECIST 1.1
- Dose Expansion: Complete Response Rate [ Time Frame: 12-24 months ]The Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1
- Dose Escalation: Objective Response Rate (ORR) of the primary tumor [ Time Frame: 12-24 months ]The Objective Response Rate (ORR) of the primary tumor, by imaging according to RECIST 1.1
- Dose Escalation: Complete Response Rate [ Time Frame: 12 months ]The Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1
- Dose Expansion: Local Progression Free Survival [ Time Frame: 12-24 months ]Local Progression Free Survival (LPFS) defined as any recurrence at the site of the primary tumor
- Dose Expansion: Progression Free Survival [ Time Frame: 12-24 months ]Progression Free Survival (PFS) defined as the time to any progression at the site of the primary tumor, in regional lymph nodes and/or distant metastasis
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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients aged ≥ 70 years old, or
- Patients aged ≥ 65 years old and < 70 years old who are unable to receive cisplatin, or
- Patients who have contraindication to cisplatin or that are intolerant to cisplatin or cetuximab or that cannot receive the combination of chemoradiation, regardless the age
- Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity or oropharynx
- T3 or T4 primary tumor or Stage III or IVA according to AJCC guidelines (8th Edition, 2018)
- No evidence of distant metastatic disease, as determined by a negative PET scan or CT scan
- Clinically eligible for intratumor implantation by injection
- Karnofsky Performance Status ≥ 70
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Adequate function of Bone marrow:
- White Blood Cell (WBC) > 3.0 x 10^9/L
- Absolute neutrophil count (ANC) > or = 1.0 x 10^9/L
- Platelet count > or = 100 x 10^9/L
- Hemoglobin > or = 9.0 g/dL
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Adequate function of Kidney:
o Creatinine < or = 3.0 x ULN or creatinine clearance > or = 30 mL/min/1.73m²
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Adequate function of the liver:
- AST < or = 5 x ULN
- ALT < or = 5 x ULN
- Bilirubin < or = 1.5 x ULN
- Negative pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential
Exclusion Criteria:
- Written Informed Consent not obtained, signed and dated
- Prior radiotherapy to any area within the planned radiotherapy field
- Tumor-related dyspnea
- Tumor ulceration which implies vascular risk
- Non measurable disease as defined by RECIST criteria
- History of stroke, CABG, or significant blockage of carotid arteries or coronary arteries or current blockage of coronary or carotid arteries equal to or in excess of 50% blockage
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
- Medical history of life-threatening ventricular arrhythmia
- Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years
- Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study
- Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
- Patients participating in another clinical investigation at the time of signature of the informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946867
Principal Investigator: | Christophe LE TOURNEAU, MD-PhD | Institut Curie Paris France |
Responsible Party: | Nanobiotix |
ClinicalTrials.gov Identifier: | NCT01946867 |
Other Study ID Numbers: |
NBTXR3-102 ID RCB: 2013-A00706-39 ( Other Identifier: Other ) |
First Posted: | September 20, 2013 Key Record Dates |
Last Update Posted: | December 29, 2022 |
Last Verified: | December 2022 |
Oral cavity Cancer Oropharynx Cancer |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |