BTXR3 With or Without Cetuximab in LA-HNSCC
- Conditions
- ocally Advanced Head and Neck Squamous Cell Carcinoma
- Registration Number
- JPRN-jRCT2051220124
- Lead Sponsor
- Floris Andriessen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Signed informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for the study, and is willing to participate in the study.
2. Age >=65 years.
3. Biopsy-confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, supraglottic larynx, or hypopharynx (archived biopsies are allowed); if no biopsies are available, a new biopsy must be obtained to provide confirmation of SCC.
4. For participants with oropharyngeal cancer, human papilloma virus (HPV) status must be known.
5. Tumor categories T3-T4 any N or T2, if >=N2 according to the 8th Edition of the AJCC Staging Manual.
6. Has one primary tumor lesion that is amenable for intratumoral injection, as determined by the Investigator.
7. Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as defined by having at least one of the following:
a. Aged >=75 years
b. Estimated creatinine clearance >=30 and <50 mL/min (calculated by Cockcroft and Gault)
c. Hearing loss or tinnitus Grade >=2
d. Grade >=2 peripheral neuropathy
e. ECOG performance status=2
f. New York Heart Association (NYHA) class III
8. Must be able to tolerate RT with curative intent as determined by the study Investigator.
9. Amenable to definitive treatment with RT. Subjects with an oral cavity cancer should not be eligible to the primary standard treatment, which is surgery, and the decision for definitive treatment with RT requires consultation with the head and neck surgeon and the site's multidisciplinary tumor board.
10. ECOG performance status of 0 to <=2.
11. Life expectancy >=6 months.
12. Adequate organ and bone marrow function at screening as defined by:
a. Hemoglobin >9.0 g/dL
b. Platelet count >100,000 cells/mm^3
c. Leukocytes >3000 cells/mm^3
d. Absolute neutrophil count >1500 cells/mm^3
e. Alanine aminotransferase <=3 x upper limit of normal (ULN)
f. Aspartate aminotransferase <=3xULN
g. Total bilirubin <=1.5 mg/dL (in participants with Gilbert's syndrome, if total bilirubin is >1.5xULN, measure directand indirect bilirubin and if direct bilirubin is <=1.5xULN, the participant may be eligible)
h. Total serum magnesium within normal ranges (1.7-2.2 mg/dL or 0.85-1.10 mmol/L) if the participant is a candidate for cetuximab treatment as per the Investigator's choice prior to randomization
1. HNSCC category T1, T2N0, T2N1, or M1 according to the 8th edition of the American Joint Committee on Cancer Staging Manual (AJCC v8).
2. Has received prior antineoplastic systemic therapy or intervention (including pharmacological - both marketed and investigational, RT, or surgery) for the treatment of HNSCC.
3. Participants with known severe Grade 3 or 4 hypersensitivity reactions to cetuximab and participants with known prior or ongoing interstitial lung disease must be excluded as a candidate for cetuximab treatment as per the Investigator's choice before randomization (these participants can still be eligible for the study, only if RT alone or NBTXR3+RT alone is chosen and documented by the Investigator before randomization).
4. Known history of human immunodeficiency virus (HIV)
Chronically ongoing active hepatitis B, or chronically ongoing active hepatitis C infection as defined in AASLD (American Association for the Study of Liver Diseases)/EASL (European Association for the Study of the Liver) guidelines.
5. Loco-regionally recurrent HNSCC that has been previously treated with chemotherapy and/or RT are not eligible for the study.
6. Ulceration or other characteristics (e.g., bleeding diathesis) that may, in the opinion of the Investigator, increase the risk of severe tumor bleeding.
7. SCC originating in the nasopharynx or paranasal sinus, from the salivary gland, or thyroid gland, or non-squamous histology (e.g., melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin.
8. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, except when:
The risk of the prior malignancy interfering with either safety or efficacy endpoints is very low; and if all treatment of that malignancy was completed at least 2 years before randomization and the subject has no clinical evidence of disease recurrence.
This exception includes completely resected/treated non-melanoma skin cancer, cervical uterine cancer, T1N0M0 invasive hormone sensitive breast cancer, hormone sensitive prostate cancer with a Gleason score of <=5, and completely resected non muscle invasive bladder cancer.
9. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second- or third-degree atrioventricular heart block without a permanent pacemaker in place).
10. Class IV congestive heart failure as defined by the New York Heart Association functional classification system <6 months prior to screening.
11. A pregnant or nursing woman, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception starting from signed ICF through 150 days after the last cetuximab dose/RT fraction. A woman who is >=1 year postmenopausal or who is surgically sterile is not considered to be of child bearing potential (pregnancy test is not required). Nursing woman could not be included in the study even in the case of breastfeeding suspension as the breastfeeding resumption could not occur during the study.
12. Ongoing areca nut (betel nut) consumption within 6 months prior to randomization.
13. Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the individual (e.g., compromises the participant's well-being) or that could prevent, limit, or confound the protocol/CIP spe
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS)