Head and Neck CancerPhase 1NCT02110992
Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study testing Docetaxel and Stereotactic Radiation in people with Head and Neck Cancer, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Docetaxel and Stereotactic Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 29 Mar 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent or second primary squamous cell head and neck cancer
- Defined area of recurrence on imaging
- Previous head and neck radiation (RT) to >/= 50 Gy
- Performance status score 0-1
- Time interval from previous RT >/= 9 months
- Volume of disease appropriate for protocol treatment
Show all 9Show fewer
- Minimum estimated survival of >/= 3 months
- Age >/= 18
- Adequate labs
Who cannot join
- Primary tumors of the salivary gland
- Original pathology report and radiation therapy records not available
- Prior spinal cord dose > 45 Gy
- Surgery or chemotherapy within 4 weeks
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267-0502
About this study
Official title: A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.
- Conditions
- Head and Neck Cancer
- Being tested
- Docetaxel, Stereotactic Radiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere, NDC 0075-8001-20
Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
Stereotactic RadiationRadiation
Also called SBRT, Stereotactic Body Radiation, Radiation Therapy
SBRT will be given over 5 fractions separated by > 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + Stereotactic Radiation | Experimental | Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours. Receives: Drug: Docetaxel; Radiation: Stereotactic Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute dose limiting toxicities
Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture
Measured: 3 months
Secondary outcomes (4)
Locoregional control
Time from enrollment until local failure or death (whichever comes first)
Measured: 2 years
Disease-free survival
Time from enrollment until disease progression anywhere in the body or death (whichever comes first)
Measured: 2 years
overall survival
Time from enrollment to death from any cause
Measured: 2 years
Number of late effect dose limiting toxicities
Occuring > 3 months after treatment completion, including grade 4 and 5 toxicities measured by CTCAE v 4.0 involving skin, mucosa, larynx, pharynx, spinal cord, cranial nerves, and incidence of caroid blowout.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brad Huth, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110992
- Sponsor's protocol ID
- UCCI-HN-13-001
- Status last verified
- Nov 2019
- First submitted
- 8 Apr 2014
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02110992
- Acronym / sponsor ID
- UCCI-HN-13-001
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + Stereotactic Radiation | Experimental | Drug: Docetaxel, Radiation: Stereotactic RadiationDocetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Recurrent or second primary squamous cell head and neck cancer
- Defined area of recurrence on imaging
- Previous head and neck radiation (RT) to >/= 50 Gy
- Performance status score 0-1
- Time interval from previous RT >/= 9 months
Key exclusion criteria (5 listed)
- Primary tumors of the salivary gland
- Original pathology report and radiation therapy records not available
- Prior spinal cord dose > 45 Gy
- Surgery or chemotherapy within 4 weeks
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere, NDC 0075-8001-20Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT | Drug | Docetaxel + Stereotactic Radiation |
| Stereotactic RadiationAlso: SBRT, Stereotactic Body Radiation, Radiation TherapySBRT will be given over 5 fractions separated by > 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy. | Radiation | Docetaxel + Stereotactic Radiation |
Primary outcome
Number of acute dose limiting toxicities
Time frame: 3 months
Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture
4 secondary outcomes
Locoregional control
Time frame: 2 years
Disease-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
Number of late effect dose limiting toxicities
Time frame: 2 years
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Huth, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel and Stereotactic Radiation in people with Head and Neck Cancer, run by University of Cincinnati at 1 site in United States.
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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Nov 2019. 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute dose limiting toxicities (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2019.