Status:
COMPLETED
Boron Neutron Capture Therapy (BNCT) for Locally Recurrent Head and Neck Cancer
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
National Tsing Hua University,Taiwan
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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. Th...
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 eligib...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01173172
Start Date
July 1 2010
End Date
March 7 2015
Last Update
February 22 2023
Active Locations (1)
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1
Cancer Center, Taipei Veterans General Hospital
Taipei, Taiwan, 11217