NANORAY-312: A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma
To evaluate survival outcomes in participants treated with intratumorally injected NBTXR3 activated by investigator's choice of radiotherapy (RT) alone or RT in combination with cetuximab in comparison to investigator's choice alone hereafter referred to as NBTXR3/RT±cetuximab versus RT±cetuximab
Age & Gender
- 65 years ~ 99 years
- Male, Female, Gender Inclusive
Visit Availability
- Standard business hours (M-F, 8-5)
- Extended hours (M-F, early morning or evening)
Location
What will be asked of you
This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study involves blood collection for research purposes in addition to routine blood work, a diagnostic imaging scan (ex: MRI/FDG-PET/CT Scan), a single intratumoral injection of NBTXR3 and 7 weeks of radiation therapy with out or without concurrent chemotherapy with Cetuximab.
Incentives
16
About 2 years
Looking for Specific Volunteers
Able to participate:
- You have locally advanced head & neck squamous cell carcinoma
- You are ineligible for platinum-based chemotherapy
- Are at least 65 years old on the day of signing the informed consent
Not eligible if:
- You have received prior chemotherapy or intervention for the treatment of Head and Neck Squamous Cell Carcinoma
- You have a known history of HIV, Chronically ongoing active hepatitis B, or chronically ongoing active hepatitis C
- You are pregnant
Contact the Team
Visit Location
Contact & Visit Location
Primary Contact
- Lineberger Clinical Trials Office
- cancerclinicaltrials@med.unc.edu
- (919) 966-4432
Primary Visit Location
Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Additional Study Information
Principal Investigator
Colette Shen
LCCC - Clinical Trials
Study Type
Clinical or Medical
Interventional
Study Topics
Cancer (Head and Neck)
IRB Number
21-1148
