A Phase I/II Trial of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Cancer at Tsing-Hua Open Pool Reactor
18 Years
80 Years
Both
Head and Neck Cancer
Trial Information
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 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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment toxicities and response rate
Outcome Description:
CTC ver 4 for toxicities RECIST for response
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Ling-Wei Wang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Center, Veterans General Hospital-Taipei, Taiwan
Authority:
Taiwan: Department of Health
Study ID:
BNCT_090514
NCT ID:
NCT01173172
Start Date:
July 2010
Completion Date:
October 2012
Related Keywords:
- Head and Neck Cancer
- Boron neutron capture therapy (BNCT)
- Head and neck cancer
- toxicities
- response rate
- Head and Neck Neoplasms
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