Back to resultsBNCT and IG-IMRT for Recurrent Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Recurrence
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
BNCT + IG-IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Boron Neutron Capture Therapy, Image-guided intensity modulation radiotherapy
Eligibility Criteria
Inclusion Criteria:
For BNCT:
- Patients with locoregionally recurrent, histologically proved malignancy of the head and neck, including primary sites of oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinus, nasal cavity, the orbit, thyroid and larynx. Pathology types like melanoma and sarcoma are also included.
- Prior conventional radiotherapy administered has been given for the disease (except melanoma).
- 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/normal tissue (T/N) ratio≧2.5 by BPA-PET scan.
For IG-IMRT:
- ECOG performance status ≦ 2
- No evidence of disease progression by physical examination or CT simulation.
- Nutrition support (feeding tube and/or IV fluid) already given for dysphagia, if present.
- Severity of mucositis and radiation dermatitis improved or downgrading, compared with those found in the 2nd or 3rd week after BNCT.
Exclusion Criteria:
For BNCT:
- 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 have 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 6 months from previous radiation therapy.
- Prior high-dose radiotherapy (Biological Effective Dose> 70 Gy/35 fractions) has been given for the present recurrent site within one year.
- Patients who had radiation myelitis or radiation necrosis of the brain/brain stem
- Time to recurrence from completion of prior surgery less than 6 months.
- Concurrent systemic cancer treatment including chemotherapy or target therapy (including cetuximab or EGFR oral tyrosine kinase inhibitor).
- 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.
For IG-IMRT:
- Any grade IV toxicity after BNCT.
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BNCT+ IG-IMRT
Arm Description
single arm
Outcomes
Primary Outcome Measures
treatment toxicities
To evaluate both acute and late toxicities after combined BNCT and IG-IMRT
response rate
including complete and partial response rate after BNCT+IG-IMRT
Secondary Outcome Measures
Time to tumor progression
defined from the date of BNCT to the date of tumor progression by clinical evaluation.
Progression-free survival
calculated from the date of BNCT to the date of cancer progression either locally or distally or to death
Full Information
NCT ID
NCT02004795
First Posted
November 11, 2013
Last Updated
December 3, 2013
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Tsing Hua University,Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02004795
Brief Title
BNCT and IG-IMRT for Recurrent Head and Neck Cancer
Official Title
A Phase I/II Trial of Boron Neutron Capture Therapy (BNCT) Combined With Image-guided Intensity Modulated Radiotherapy (IG-IMRT) for Locally Recurrent Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Tsing Hua University,Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a boron neutron capture therapy (BNCT) combined with image-guided intensity modulation radiotherapy (IG-IMRT) 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(H & N) 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 intravenous infusion, the tumor site is irradiated with neutrons, the source of which is currently a nuclear reactor, like the Tsing Hua Open-Pool Reactor (THOR), a 2MW research reactor at National Tsing Hua University (NTHU) in Taiwan. Since it is a target radiotherapy, low complication rate after BNCT can be obtained. However, further local recurrence after BNCT for recurrent H & N cancer was reported in several publications.
Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the approved radiation treatment plan. IGRT such as Cone-Beam CT (CBCT) using an On-Board Imager (OBI) enhance delivery and further improve outcomes as the treatments create a higher level of precision. By combining BNCT and IG-IMRT, we expect to procure high control rate of recurrent H & N cancer with acceptable toxicity. This study will be the first BNCT plus IG-IMRT trial to treat head and neck cancer in Taiwan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Recurrence
Keywords
Boron Neutron Capture Therapy, Image-guided intensity modulation radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BNCT+ IG-IMRT
Arm Type
Experimental
Arm Description
single arm
Intervention Type
Radiation
Intervention Name(s)
BNCT + IG-IMRT
Intervention Description
Single faction of BNCT (20 Gy) plus IG-IMRT (40 Gy/20 fractions)
Primary Outcome Measure Information:
Title
treatment toxicities
Description
To evaluate both acute and late toxicities after combined BNCT and IG-IMRT
Time Frame
two years after combined treatment
Title
response rate
Description
including complete and partial response rate after BNCT+IG-IMRT
Time Frame
Three months after combined treatment
Secondary Outcome Measure Information:
Title
Time to tumor progression
Description
defined from the date of BNCT to the date of tumor progression by clinical evaluation.
Time Frame
two years
Title
Progression-free survival
Description
calculated from the date of BNCT to the date of cancer progression either locally or distally or to death
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For BNCT:
Patients with locoregionally recurrent, histologically proved malignancy of the head and neck, including primary sites of oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinus, nasal cavity, the orbit, thyroid and larynx. Pathology types like melanoma and sarcoma are also included.
Prior conventional radiotherapy administered has been given for the disease (except melanoma).
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/normal tissue (T/N) ratio≧2.5 by BPA-PET scan.
For IG-IMRT:
ECOG performance status ≦ 2
No evidence of disease progression by physical examination or CT simulation.
Nutrition support (feeding tube and/or IV fluid) already given for dysphagia, if present.
Severity of mucositis and radiation dermatitis improved or downgrading, compared with those found in the 2nd or 3rd week after BNCT.
Exclusion Criteria:
For BNCT:
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 have 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 6 months from previous radiation therapy.
Prior high-dose radiotherapy (Biological Effective Dose> 70 Gy/35 fractions) has been given for the present recurrent site within one year.
Patients who had radiation myelitis or radiation necrosis of the brain/brain stem
Time to recurrence from completion of prior surgery less than 6 months.
Concurrent systemic cancer treatment including chemotherapy or target therapy (including cetuximab or EGFR oral tyrosine kinase inhibitor).
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.
For IG-IMRT:
Any grade IV toxicity after BNCT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling-Wei Wang, MD
Phone
886-2-28757270
Ext
308
Email
lingweiw@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Wei Chen, MD, PhD
Phone
886-2-28757270
Ext
399
Email
chenyw@vghtpe.gov.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling-Wei Wang, MD
12. IPD Sharing Statement
Learn more about this trial
BNCT and IG-IMRT for Recurrent Head and Neck Cancer
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