Status:
COMPLETED
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment Head and Neck Tumors
Lead Sponsor:
Boneca Corporation
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is based on the principle of irradiating boron atoms with neutrons. When neutrons have relatively low energy, ...
Detailed Description
This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II trial to determine the value of BNCT in the treatment of inoperable, irradiated, locally advanced cancers of ...
Eligibility Criteria
Inclusion
- Histologically confirmed, malignant head and neck cancer.
- Inoperable tumor, prior surgery may or may not have been done.
- Prior radiotherapy or chemoradiotherapy has been given.
- If prior SPECT or PET with 18F-BFA has been done, BPA needs to accumulate at least 2.5 times more in the tumor than in the corresponding contralateral normal tissue.
- WHO performance status \<3.
- WBC \>2,500/mm3, platelets \>75,000/mm3, serum creatinine \<180 umol/L.
- A written informed consent.
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.
- A non-experimental, effective treatment option is available.
- Expected survival less than 3 months.
- Concomitant systemic chemotherapy (prior cancer chemotherapy is allowed).
- Other concurrent experimental therapy, or such therapy is being planned to be given.
- Less than 3 months since prior radiation therapy.
- Untreated or severe, treated congestive heart failure or renal failure.
- A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning.
- Restlessness or inability to lie in a cast for 30 to 60 minutes.
- Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in follow-up.
- Pregnancy.
- Age less than 18.
- The patient is not able to understand the treatment options.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00114790
Start Date
December 1 2003
End Date
January 1 2012
Last Update
May 6 2013
Active Locations (1)
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1
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029