Study Stopped
The neutron facility closed down for financial reasons.
Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck Cancer
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) Combined With Anti-erbB1 Antibody Therapy in the Treatment of Locally Recurred Head and Neck Cancer: A Phase I/II Study.
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of the study is to investigate efficacy and safety boron neutron capture therapy (BNCT) administered in combination with cetuximab in the treatment of head and neck cancer that has recurred locally following conventional cancer treatment (surgery and radiation therapy). Boron neutron capture therapy is a special form of radiation therapy, which is based on interaction between boron atoms taken up by the cancerous tissue and neutron irradiation. The boron atoms, located within cancer cells, may capture low-energy neutrons obtained from a nuclear accelerator, which results in splitting up (fission) of the boron atoms, and a high radiation effect within the tumor. Cetuximab is an antibody directed against certain proteins found on cancer cell surface (epidermal growth factor receptors). When administered immediately after BNCT, cetuximab may or may not improve treatment efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 head-and-neck-cancer
Started Jun 2009
Typical duration for phase_1 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 21, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 31, 2017
January 1, 2017
4 years
June 21, 2009
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
December 2010
Secondary Outcomes (5)
Safety
December 2010
Duration of treatment response
December 2010
Time to progression
December 2010
Survival
December 2010
Adverse events
December 2010
Study Arms (1)
BNCT plus cetuximab
EXPERIMENTALPatients treated with BNCT followed by cetuximab administration
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed invasive squamous cell carcinoma of the head and neck
- Inoperable tumor or the patient is not a candidate for surgery for medical reasons; prior surgery may or may not have been done
- Prior radiotherapy or chemoradiotherapy has been given to the tumor
- If prior 18F-boronophenylalanine (BPA) PET (positron emission tomography)has been done, BPA needs to accumulate at least 2 times more in the tumor than in the corresponding normal tissue
- A written informed consent
You may not qualify if:
- Presence of distant metastases
- A non-experimental, effective treatment op-tion is available
- WHO performance status \>3
- WBC \<2,500/mm3, platelets \<75,000/mm3, serum creatinine \>180 umol/L
- Concomitant systemic cancer chemotherapy (except cetuximab).
- Other concurrent experimental therapy
- Less than 1 month since prior radiation therapy
- Untreated or severe treated congestive heart failure or renal failure
- A cardiac pace-maker or unremovable metal implants 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
- Known allergy/hypersensitivity to cetuximab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oncology, Helsinki University Central Hospital
Helsinki, FIN-00029, Finland
Related Publications (1)
Kankaanranta L, Seppala T, Koivunoro H, Saarilahti K, Atula T, Collan J, Salli E, Kortesniemi M, Uusi-Simola J, Makitie A, Seppanen M, Minn H, Kotiluoto P, Auterinen I, Savolainen S, Kouri M, Joensuu H. Boron neutron capture therapy in the treatment of locally recurred head and neck cancer. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):475-82. doi: 10.1016/j.ijrobp.2007.03.039. Epub 2007 Aug 6.
PMID: 17689034BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Heikki Joensuu, MD
Department of Oncology, Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2009
First Posted
June 24, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
January 31, 2017
Record last verified: 2017-01