Boron Neutron Capture Therapy (BNCT) for Locally Recurrent Head and Neck Cancer (BNCT)
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|ClinicalTrials.gov Identifier: NCT01173172|
Recruitment Status : Unknown
Verified April 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was: Recruiting
First Posted : July 30, 2010
Last Update Posted : August 3, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Radiation: Boron Neutron Capture Therapy||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||October 2012|
Experimental: BNCT, recurrent head and neck cancer
Single arm treated by BNCT only
Radiation: Boron Neutron Capture Therapy
Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)
- Treatment toxicities and response rate [ Time Frame: 2 years ]CTC ver 4 for toxicities RECIST for response
- 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 ]Health-related quality of life will be measured before and after BNCT at regular intervals
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173172
|Contact: Ling-Wei Wang, MD||886-2-28757270 ext firstname.lastname@example.org|
|Contact: Sang-Hue Yen, MDemail@example.com|
|Cancer Center, Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 11217|
|Principal Investigator: Ling-Wei Wang, MD|
|Principal Investigator:||Ling-Wei Wang, MD||Cancer Center, Veterans General Hospital-Taipei, Taiwan|