BNCT and IG-IMRT for Recurrent Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02004795|
Recruitment Status : Unknown
Verified November 2013 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was: Recruiting
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Recurrence||Radiation: BNCT + IG-IMRT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2018|
Experimental: BNCT+ IG-IMRT
Radiation: BNCT + IG-IMRT
Single faction of BNCT (20 Gy) plus IG-IMRT (40 Gy/20 fractions)
- treatment toxicities [ Time Frame: two years after combined treatment ]To evaluate both acute and late toxicities after combined BNCT and IG-IMRT
- response rate [ Time Frame: Three months after combined treatment ]including complete and partial response rate after BNCT+IG-IMRT
- Time to tumor progression [ Time Frame: two years ]defined from the date of BNCT to the date of tumor progression by clinical evaluation.
- Progression-free survival [ Time Frame: two years ]calculated from the date of BNCT to the date of cancer progression either locally or distally or to death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004795
|Contact: Ling-Wei Wang, MD||886-2-28757270 ext email@example.com|
|Contact: Yi-Wei Chen, MD, PhD||886-2-28757270 ext firstname.lastname@example.org|
|Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 112|
|Principal Investigator: Ling-Wei Wang, MD|