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Head and Neck CancerPhase 1ST-BNCT2001NCT05883007

Dose Optimized BNCT for Head and Neck Cancer

A Phase 1 study testing Accelerator-based BNCT with borofalan(10B) in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by Southern Tohoku BNCT Research Center at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety of applying BNCT with the dose optimization in patients with recurrent head and neck cancer. The main questions it aims to answer are: Dose optimized BNCT are conducted safety in these patients. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Head and Neck Cancer, Squamous Cell Carcinoma
What is being tested?
Accelerator-based BNCT with borofalan(10B)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteJapan
Study dates
1 Jun 2020to 31 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent to participate in the clinical trial on their own free will.
  • Aged over 20 years at the time of consent obtaining.
  • ECOG performance status (PS) of 0-2.
  • Histologically confirmed a primary lesion of Head and Neck cancer.
  • Following condition:
  • Locally Recurrent Head and Neck Squamous Cell Carcinoma after chemo radiotherapy or radiation therapy.
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  • Primary Head or Neck Squamous Cell Carcinoma with no indicated of radical radiation therapy for the target lesions.
  • More than one the target lesions based on RECIST (version 1.1)
  • Local recurrent lesion localized to unilateral.
  • Received a fractionated radiation therapy with total doses of ≥40 and ≤80 Gy at around 2 Gy per daily fraction at target lesion sites or an equivalent biologically effective dose.
  • ≥50 days have passed since the last irradiation date of the prior radiation therapy at target lesion sites to the day of scheduled BNCT
  • Have an estimated survival of ≥90 days after BNCT.
  • Estimated able to receive the minimum tumor dose at least 20Gy-Eq.
  • Screening test values that meet the following criteria.
  • No abnormal findings of clinical concern in chest X-ray exam.

Who cannot join

  • Active multiple primary cancers.
  • Distant metastatic lesions.
  • Active infections requiring systemic treatment.
  • Serious complications.
  • Poorly controlled diabetes mellitus.
  • Poorly controlled hypertension.
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  • Chronic lung diseases.
  • Kidney diseases.
  • Cardiac diseases.
  • Other serious complications.
  • Phenylketonuria.
  • Hereditary fructose intolerance.
  • Current or past medical history of serious hypersensitivity to drugs or contrast media.
  • Myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
  • Grade ≥3 (CTCAE v4.0) symptom at the target site.
  • Tumor invasion of the carotid artery or adjacent to over half of the carotid artery.
  • Dental caries whose treatment has not been completed.
  • Received antitumor drugs within 4 weeks prior to the scheduled BNCT.
  • Participating in a clinical study of an unapproved drug except 18F-F BPA-PET/CT examinations within 4 weeks prior to the scheduled BNCT.
  • Implanted with a cardiac pacemaker, ventricular assist device, or the like.
  • Inability to immobilize at a right position during irradiation by the investigator (subinvestigator)
  • Pregnant or who are breastfeeding during the period of the clinical trial.
  • Mental illness or mental conditions.
  • Poorly controlled epilepsy.
  • Unable to comply with the protocol and to attend follow-up visits.
  • With a history of BNCT.
  • Considered unfit to participate in this clinical trial as assessed by the investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Southern Tohoku BNCT Research Center

    Kōriyama, Fukushima, 9638052

Other trials in Japan

About this study

Official title: Safety Cohort Study for Dose Optimization of Accelerator-based BPA-BNCT in Patients With Unresectable Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (ST-BNCT2001)

The goal of this clinical trial is to evaluate the safety of applying BNCT with the dose optimization in patients with recurrent head and neck cancer. The main questions it aims to answer are:

  • Dose optimized BNCT are conducted safety in these patients. Participants will receive dose optimized BNCT regulated as 12, 15, 18 Gy-Eq of the mucosal dose.
Being tested
Accelerator-based BNCT with borofalan(10B)
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accelerator-based BNCT with borofalan(10B)Radiation

    Patients will be treated with BNCT regulated as 12, 15, or 18 Gy-Eq of the mucosal maximum dose.

Study groups in NCT05883007
Study groupRoleWhat they receive
Dose-optimized BNCT with borofalan(10B)ExperimentalNot described
Receives: Radiation: Accelerator-based BNCT with borofalan(10B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (Absence and presence of serious adverse events)

    Grade 3 or higher adverse events as evaluated in CTCAEv5.1 Number of participants with severe adverse events due to an excess of tissue tolerance dose

    Measured: Within 90days after the completion of BNCT

Secondary outcomes (8)

  1. Objective response rate: ORR

    ORR within 90 days after the completion of BNCT is evaluated using RECIST guidelines (version 1.1).

    ORR is defined as the percentage of subjects with CR and PR in the target lesions among all eligible subjects.

    Measured: Within 90 days after the completion of BNCT

  2. Duration of Response

    The duration of the response is the time from the confirmed achievement of CR or PR (whichever is recorded first) to the date of initial objectively confirmed recurrence or exacerbation.

    Measured: Within 2 years after the completion of BNCT

  3. Disease control rate (DCR)

    DCR is evaluated using RECIST guidelines (version 1.1). DCR is defined as the proportion of subjects with CR, PR, or SD in the target lesions among all eligible subjects.

    Measured: Within 90 days after the completion of BNCT

  4. Overall survival (OS)

    OS is defined as the time from the day of the completion of BNCT to death due to all causes. The survey period will be up to the completion of the follow-up survey for all subjects.

    Measured: Within 2 years after the completion of BNCT or up to the end of this study

  5. Progression-Free Survival (PFS)

    PFS is defined as the time from the day of the completion of BNCT to the date of initial confirmed PD. The survey period will be up to the completion of the follow-up survey for all subjects.

    Measured: Within 2 years after the completion of BNCT or up to the end of this study

  6. Late Adverse Events

    The late Adverse Events are defined as the medical occurrence of the study from the treatment periods to the follow-up periods.

    Measured: From 90 days to 2 years after the completion of BNCT

  7. Quality of life (QOL) Score Based on EORTC QLQ C30 and H&N35.

    QOL score is assessed with EORTC QLQ C30 and H\&N35 in the follow-up period. Results are scored as a specified manner by EORTC and changes in scores during the follow up period are evaluated

    Measured: Within 2 years after the completion of BNCT or up to the end of this study

  8. Quality-Adjusted Life Year (QALY)

    QOL and life year are multiplied to calculate the QALY. QOL score based on EQ-5D-5L in Japanese version.

    Measured: Within 2 years after the completion of BNCT or up to the end of this study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start1 Jun 2020
  3. Primary completion31 May 2022
  4. Study completion31 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05883007
Sponsor's protocol ID
ST-BNCT2001
Acronym
ST-BNCT2001
Status last verified
May 2023
First submitted
16 May 2023
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Accelerator-based BNCT with borofalan(10B) in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by Southern Tohoku BNCT Research Center at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (Absence and presence of serious adverse events) (time frame: Within 90days after the completion of BNCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05883007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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