NCT05883007

Brief 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. Participants will receive dose optimized BNCT regulated as 12, 15, 18 Gy-Eq of the mucosal dose.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Jun 2020

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 16, 2023

Last Update Submit

June 2, 2023

Conditions

Head and Neck CancerSquamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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

    Within 90days after the completion of BNCT

Secondary Outcomes (8)

  • Objective response rate: ORR

    Within 90 days after the completion of BNCT

  • Duration of Response

    Within 2 years after the completion of BNCT

  • Disease control rate (DCR)

    Within 90 days after the completion of BNCT

  • Overall survival (OS)

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

  • Progression-Free Survival (PFS)

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

  • +3 more secondary outcomes

Study Arms (1)

Dose-optimized BNCT with borofalan(10B)

EXPERIMENTAL
Radiation: Accelerator-based BNCT with borofalan(10B)

Interventions

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.

Dose-optimized BNCT with borofalan(10B)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Active multiple primary cancers.
  • Distant metastatic lesions.
  • Active infections requiring systemic treatment.
  • Serious complications.
  • Poorly controlled diabetes mellitus.
  • Poorly controlled hypertension.
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Tohoku BNCT Research Center

Kōriyama, Fukushima, 9638052, Japan

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 31, 2023

Study Start

June 1, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2024

Last Updated

June 5, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)