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Boron Neutron Capture Therapy (BNCT) for Locally Recurrent Head and Neck Cancer

NCT01173172 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-02-22

No results posted yet for this study

Summary

This is a boron neutron capture (BNCT) therapy for patients with previously irradiated and locally recurrent head and neck cancer. The primary end points are treatment toxicities and response rate. The secondary endpoints are time to tumor progression, progression-free survival, overall survival and change quality of life.

Head and neck carcinomas that recur locally after conventional irradiation pose a therapeutic challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture reaction that occurs when non-radioactive boron is irradiated with neutrons of thermal energy to yield high energy alpha particles and recoiling lithium nuclei. The effect of alpha and 7Li is primarily limited to boron- containing cells. Preferential uptake of boron into cancerous tissue is achieved using boron carriers such as a derivative of phenylalanine, boronophenylalanine (BPA). After administration of BPA by an intra-arterial or intravenous infusion, the tumor site is irradiated with neutrons, the source of which is currently a nuclear reactor. A few uncontrolled clinical trials have evaluated BNCT in the treatment of glioblastoma after brain surgery. In these studies, the median survival times have been 13-15 months after BNCT. However, efficacy and tolerability of BNCT in the treatment of limited number of head and neck cancer patients showed promising results. Though many basic researches about BNCT has been done using Tsing Hua Open-pool Reactor (THOR) at National Tsing Hua University, no clinical trial utilizing BNCT is performed in our country. This study will be the first BNCT trial to treat head and neck cancer in Taiwan.

Conditions

Interventions

RADIATION

Boron Neutron Capture Therapy

Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)

Sponsors & Collaborators

  • National Tsing Hua University,Taiwan

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Ling-Wei Wang, MD · Cancer Center, Veterans General Hospital-Taipei, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-03-07
Completion
2015-03-07

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173172 on ClinicalTrials.gov