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Trial Title:
BNCT and IG-IMRT for Recurrent Head and Neck Cancer
NCT ID:
NCT02004795
Condition:
Head and Neck Cancer
Recurrence
Conditions: Official terms:
Head and Neck Neoplasms
Recurrence
Conditions: Keywords:
Boron Neutron Capture Therapy
Image-guided intensity modulation radiotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
BNCT + IG-IMRT
Description:
Single faction of BNCT (20 Gy) plus IG-IMRT (40 Gy/20 fractions)
Arm group label:
BNCT+ IG-IMRT
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For BNCT:
1. 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.
2. Prior conventional radiotherapy administered has been given for the disease
(except melanoma).
3. Bi-dimensionally measurable disease by MRI and/or CT scan and ≦ 12 cm in
largest dimension.
4. Age greater than 18 years and < 80 years, ECOG performance status ≦ 2
5. WBC > 2.5 x109/L, neutrophil count >1.0 x109/L, platelet count >75x109/L, serum
creatinine <1.25xULN.
6. Informed consent signed.
7. Tumor/normal tissue (T/N) ratio≧2.5 by BPA-PET scan.
- For IG-IMRT:
1. ECOG performance status ≦ 2
2. No evidence of disease progression by physical examination or CT simulation.
3. Nutrition support (feeding tube and/or IV fluid) already given for dysphagia,
if present.
4. 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:
1. 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.
2. Patients who have an effective standard treatment option available.
3. Distant metastasis outside of the head and neck region.
4. Expecting life less than 3 months.
5. A time interval less than 6 months from previous radiation therapy.
6. Prior high-dose radiotherapy (Biological Effective Dose> 70 Gy/35 fractions)
has been given for the present recurrent site within one year.
7. Patients who had radiation myelitis or radiation necrosis of the brain/brain
stem
8. Time to recurrence from completion of prior surgery less than 6 months.
9. Concurrent systemic cancer treatment including chemotherapy or target therapy
(including cetuximab or EGFR oral tyrosine kinase inhibitor).
10. Severe congestive heart failure or renal failure.
11. Pregnancy
12. Restless patients who were unable to lie or sit in a cast for 30-60 min.
13. 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:
1. Any grade IV toxicity after BNCT.
Gender:
All
Minimum age:
19 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Ling-Wei Wang, MD
Email:
Principal Investigator
Start date:
November 2013
Completion date:
November 2018
Lead sponsor:
Agency:
Taipei Veterans General Hospital, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Tsing Hua University,Taiwan
Agency class:
Other
Source:
Taipei Veterans General Hospital, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02004795