Long-term outcome of concurrent chemotherapy and reirradiation for recurrent and second primary head-and-neck squamous cell carcinoma.
Joseph K Salama, Everett E Vokes, Steven J Chmura...
https://pubmed.ncbi.nlm.nih.gov/16213104Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID07058116
Accelerator-based Boron Neutron Capture Therapy (BNCT) in the Treatment of Locally Recurrent Head and Neck Carcinoma: A Phase I Study
Led by Neutron Therapeutics, LLC · Updated on 2025-07-10
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
Neutron Therapeutics, LLC
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new type of radiation treatment called accelerator-based boron neutron capture therapy (BNCT) for patients with head and neck carcinoma that has returned locally after conventional radiation therapy. This phase I study, sponsored by Neutron Therapeutics, aims primarily to evaluate the safety of delivering BNCT using the nuBeam Suite. The study also examines the ability to deliver the planned radiation dose accurately and to effectively plan and target the tumor using advanced imaging and robotic positioning systems. Secondary goals include measuring tumor response, survival outcomes, and quality of life. The treatment involves administering a drug called L-boronophenylalanine complexed with fructose intravenously over two hours before neutron irradiation. Each participant will receive two BNCT treatments spaced about four weeks apart. The nuBeam Suite, which includes a therapeutic neutron source and a patient positioning system with CT imaging, delivers a targeted neutron beam to the tumor area. The trial does not involve randomization and uses a dose escalation design with up to ten participants in three groups to assess safety. Participants will be closely monitored through various assessments including safety evaluations one month after the final treatment. Researchers will track adverse events, tumor response using imaging, and survival rates over time. The study includes detailed treatment planning, patient positioning, and follow-up visits to ensure accurate delivery of therapy and to evaluate outcomes such as duration of tumor response and progression-free survival. The entire research process is expected to last about 13 months, with participant enrollment anticipated to take 12 months.
CONDITIONS
Brief Title
Accelerator-based BNCT (Boron Neutron Capture Therapy) for Head and Neck Carcinoma.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provided written informed consent prior to screening, with the right to withdraw at any time
- At least 18 years of age at enrollment
- Histologically confirmed head and neck carcinoma
- Cancer is inoperable; prior surgery may or may not have been performed
- Received prior radiotherapy or chemoradiotherapy
- Anticipated life expectancy of at least 6 months
You will not qualify if you...
- Presence of distant metastases
- WHO performance status greater than 2
- Concurrent uncontrolled cancer other than head and neck carcinoma or metastatic cancer
- Availability of a non-experimental, effective treatment option suitable for the patient
- Receiving concomitant chemotherapy
- Participation in another experimental therapy within 3 months prior to inclusion
- Less than 3 months since prior radiation therapy
- Major surgery within 4 weeks prior to inclusion
- Unremovable metal implants in head and neck region interfering with imaging
- Known sensitivity to the study drug
- Blood or liver function abnormalities (e.g., low hemoglobin, neutrophils, platelets, high creatinine, bilirubin, ALT, AST, alkaline phosphatase)
- Serious uncontrolled infection or other serious diseases
- Collagen vascular disease or conditions increasing radiation sensitivity
- Unwilling or unable to comply with required follow-up visits
- Untreated or severe heart failure, cardiac pacemaker, or renal failure
- Inability to lie still for about 30 minutes
- Inability or unwillingness to participate in clinical follow-up
- Known pregnancy, breastfeeding, or planning pregnancy; negative pregnancy test required for women of childbearing potential
- Inability to understand the study and treatment options
- Phenylketonuria
- Fructose intolerance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 4 to 6 weeks
Participants receive two BNCT trial treatments with L-Boronophenylalanine administered intravenously before neutron irradiation. The treatments are spaced 3 to 6 weeks apart and delivered using the nuBeam Suite at the Helsinki University Hospital BNCT facility.
2 treatment visits (in-person)
Follow-up
Duration - Up to 13 months
Participants are monitored for safety, treatment response, and effectiveness up to 13 months after the final BNCT trial treatment.
Periodic follow-up visits for assessment up to 13 months
Trial Site Locations
Total: 1 location
1
Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
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Research Team
A
Anu Anttonen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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