Head and Neck CancerPhase 1/2BNCTNCT01173172
Boron Neutron Capture Therapy (BNCT) for Locally Recurrent Head and Neck Cancer
A Phase 1/2 study testing Boron Neutron Capture Therapy in people with Head and Neck Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Boron Neutron Capture Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2010to 7 Mar 2015
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locoregionally recurrent, histologically proved malignancy of the head and neck.
- Prior conventional radiotherapy administered has been given for the disease (except melanoma) and surgery, conventional radiotherapy or chemotherapy are not appropriate for salvage.
- Bi-dimensionally measurable disease by MRI and/or CT scan and ≦ 12 cm in largest dimension.
- Age greater than 18 years and < 80 years, ECOG performance status ≦ 2
- WBC > 2.5 x109/L, neutrophil count >1.0 x109/L, platelet count >75x109/L, serum creatinine <1.25xULN.
- Informed consent signed.
- Tumor to Normal tissue (T/N) ratio for BPA >2.5 by 18F-BPA PET scan.
Who cannot join
- Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
- Patients who had an effective standard treatment option available.
- Distant metastasis outside of the head and neck region.
- Expecting life less than 3 months.
- A time interval less than 3 months from previous radiation therapy.
- Concurrent systemic cancer treatment including chemotherapy or target therapy.
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- Severe congestive heart failure or renal failure.
- Pregnancy.
- Restless patients who were unable to lie or sit in a cast for 30-60 min.
- A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning or tumor response evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Trial of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Cancer at Tsing-Hua Open Pool Reactor
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.
Read the detailed description
This is a prospective, single arm, open label phase I/II trial with boron neutron capture (BNCT) therapy for patients with previously irradiated and locally recurrent head and neck cancer.
The eligibility criteria are patients with locoregionally recurrent head and neck cancer; good performance status; inoperable, clinical measurable tumor size; good organ function and good compliance. No systemic treatment is in use. Once entering this study, patients will receive angiographies to evaluate bloody supply of the tumor and PET scan with 18F-fluoro-L-BPA as the tracer. Tumor-to- normal tissue ratios were evaluated from static emission scans. Boron concentration of normal tissues is derived from measurement of BPA concentration in the blood. Treatment planning with THORplan will be done after Computerized Tomography (CT) simulation. After treatment plan approved and on the day of treatment, intravenous or intra-arterial L-BPA- Fructose complex 500 mg/kg was administered at a constant rate over about 3 hours before and during neutron irradiation. Neutron beam irradiations were given at the THOR with prescription dose of 20 to 25 Gy (Eq) for the tumor in one fraction on day 1 and repeated on day 30. Patients will be regularly followed up at OPD for toxicities (NCI Common Terminology Criteria) and response evaluation (RECIST criteria)by MRI and PET, time to progression measurement, survival status and change of quality of life. Maximally 27 patients will be enrolled. After first 10 patients, the preliminary results will be reviewed before further patients' enrollment.
- Conditions
- Head and Neck Cancer
- Being tested
- Boron Neutron Capture Therapy
- Keywords
- Boron neutron capture therapy (BNCT), Head and neck cancer, toxicities, response rate
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boron Neutron Capture TherapyRadiation
Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)
| Study group | Role | What they receive |
|---|---|---|
| BNCT, recurrent head and neck cancer | Experimental | Single arm treated by BNCT only Receives: Radiation: Boron Neutron Capture Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment toxicities and response rate
CTC ver 4 for toxicities RECIST for response
Measured: 2 years
Secondary outcomes (4)
Time to tumor progression
Interval between enrollment to disease progression
Measured: 5 year
Progression-free survival
Percentage of patients without any disease progression at a time point
Measured: 5 years
overall survival
Percentage of surviving patients at a time point
Measured: 5 year
Change of quality of life
Health-related quality of life will be measured before and after BNCT at regular intervals
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2010
- Primary completion7 Mar 2014
- Study completion7 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Tsing Hua University,Taiwan
- Responsible party
- Sponsor
- Investigators
- Ling-Wei Wang, MD, Principal investigator, Cancer Center, Veterans General Hospital-Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173172
- Sponsor's protocol ID
- BNCT_090514
- Acronym
- BNCT
- Status last verified
- Feb 2023
- First submitted
- 28 Jul 2010
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Cancer at Tsing-Hua Open Pool Reactor
- ClinicalTrials.gov ID
- NCT01173172
- Acronym / sponsor ID
- BNCT / BNCT_090514
- Conditions
- Head and Neck Cancer
- Keywords
- Boron neutron capture therapy (BNCT), Head and neck cancer, toxicities, response rate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Tsing Hua University,Taiwan
- Study start
- Jul 2010 (actual)
- Primary completion
- 7 Mar 2014 (actual)
- Study completion
- 7 Mar 2015 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single arm, open label phase I/II trial with boron neutron capture (BNCT) therapy for patients with previously irradiated and locally recurrent head and neck cancer.
The eligibility criteria are patients with locoregionally recurrent head and neck cancer; good performance status; inoperable, clinical measurable tumor size; good organ function and good compliance. No systemic treatment is in use. Once entering this study, patients will receive angiographies to evaluate bloody supply of the tumor and PET scan with 18F-fluoro-L-BPA as the tracer. Tumor-to- normal tissue ratios were evaluated from static emission scans. Boron concentration of normal tissues is derived from measurement of BPA concentration in the blood. Treatment planning with THORplan will be done after Computerized Tomography (CT) simulation. After treatment plan approved and on the day of treatment, intravenous or intra-arterial L-BPA- Fructose complex 500 mg/kg was administered at a constant rate over about 3 hours before and during neutron irradiation. Neutron beam irradiations were given at the THOR with prescription dose of 20 to 25 Gy (Eq) for the tumor in one fraction on day 1 and repeated on day 30. Patients will be regularly followed up at OPD for toxicities (NCI Common Terminology Criteria) and response evaluation (RECIST criteria)by MRI and PET, time to progression measurement, survival status and change of quality of life. Maximally 27 patients will be enrolled. After first 10 patients, the preliminary results will be reviewed before further patients' enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNCT, recurrent head and neck cancer | Experimental | Radiation: Boron Neutron Capture TherapySingle arm treated by BNCT only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with locoregionally recurrent, histologically proved malignancy of the head and neck.
- Prior conventional radiotherapy administered has been given for the disease (except melanoma) and surgery, conventional radiotherapy or chemotherapy are not appropriate for salvage.
- Bi-dimensionally measurable disease by MRI and/or CT scan and ≦ 12 cm in largest dimension.
- Age greater than 18 years and < 80 years, ECOG performance status ≦ 2
- WBC > 2.5 x109/L, neutrophil count >1.0 x109/L, platelet count >75x109/L, serum creatinine <1.25xULN.
Key exclusion criteria (10 listed)
- Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
- Patients who had an effective standard treatment option available.
- Distant metastasis outside of the head and neck region.
- Expecting life less than 3 months.
- A time interval less than 3 months from previous radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boron Neutron Capture TherapyBoronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30) | Radiation | BNCT, recurrent head and neck cancer |
Primary outcome
Treatment toxicities and response rate
Time frame: 2 years
CTC ver 4 for toxicities RECIST for response
4 secondary outcomes
Time to tumor progression
Time frame: 5 year
Progression-free survival
Time frame: 5 years
overall survival
Time frame: 5 year
Change of quality of life
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling-Wei Wang, MD principal investigator
Cancer Center, Veterans General Hospital-Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Boron Neutron Capture Therapy in people with Head and Neck Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 22 Feb 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 Taiwan. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment toxicities and response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2023.