NBTXR3 and Radiation Therapy in Treating Patients With Locally Advanced SCC of the Oral Cavity or… (NCT01946867) | Clinical Trial Compass
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NBTXR3 and Radiation Therapy in Treating Patients With Locally Advanced SCC of the Oral Cavity or Oropharynx
France, Hungary, Poland75 participantsStarted 2014-01-03
Plain-language summary
RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions. The incidence of Head and Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population as recorded by the Surveillance, Epidemiology, and End Results registries in the United States. Regarding the therapeutic strategies, the association of radiotherapy with chemotherapy or biologics has demonstrated significant improvement of outcomes with the drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell killing and complete tumor shrinkage allowing a definitive treatment and preservation of local structures and functions in patients older 65 years, who cannot receive cisplatin.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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
* Adequate function of Kidney:
o Creatinine \< or = 3.0 x ULN or creatinine clearance \> or = 30 mL/min/1.73m²
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Escalation: Incidence of DLTs and determination of the Recommended Phase 2 Dose
Timeframe: 12 months
2
Dose Escalation: Determination of the Recommended Phase 2 Dose