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Head and Neck CancerPhase 1/2NCT02004795

BNCT and IG-IMRT for Recurrent Head and Neck Cancer

A Phase 1/2 study testing BNCT + IG-IMRT in people with Head and Neck Cancer and Recurrence, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 79 years
Conditions the study is for
Head and Neck Cancer, Recurrence
What is being tested?
BNCT + IG-IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTaiwan
Study dates
Nov 2013to Nov 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Ling-Wei Wang, MD contact

886-2-28757270 ext. 308

lingweiw@gmail.com

Yi-Wei Chen, MD, PhD contact

886-2-28757270 ext. 399

chenyw@vghtpe.gov.tw

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei, Taiwan, 112

    Ling-Wei Wang, MD

    Recruiting

Other trials in Taiwan

About this study

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

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.

Being tested
BNCT + IG-IMRT
Keywords
Boron Neutron Capture Therapy, Image-guided intensity modulation radiotherapy
Medical subject headings
Head and Neck Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNCT + IG-IMRTRadiation

    Single faction of BNCT (20 Gy) plus IG-IMRT (40 Gy/20 fractions)

Study groups in NCT02004795
Study groupRoleWhat they receive
BNCT+ IG-IMRTExperimentalsingle arm
Receives: Radiation: BNCT + IG-IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment toxicities

    To evaluate both acute and late toxicities after combined BNCT and IG-IMRT

    Measured: two years after combined treatment

  2. response rate

    including complete and partial response rate after BNCT+IG-IMRT

    Measured: Three months after combined treatment

Secondary outcomes (2)

  1. Time to tumor progression

    defined from the date of BNCT to the date of tumor progression by clinical evaluation.

    Measured: two years

  2. Progression-free survival

    calculated from the date of BNCT to the date of cancer progression either locally or distally or to death

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2016 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004795
Sponsor's protocol ID
2012-06-016A
Status last verified
Nov 2013
First submitted
11 Nov 2013
Last updated
9 Dec 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNCT + IG-IMRT in people with Head and Neck Cancer and Recurrence, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ling-Wei Wang, MD (886-2-28757270 ext. 308, lingweiw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment toxicities (time frame: two years after combined treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.

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