Early-stage Glottic Larynx CancerPhase 1NCT01984502
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
A Phase 1 study testing CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy in people with Early-stage Glottic Larynx Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose fraction reduction study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Early-stage Glottic Larynx Cancer
- What is being tested?
- CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2013to 31 May 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3.1.1 Stage Tis, T1, or T2 laryngeal squamous cancer as defined by American Joint Commission on Cancer (AJCC) 2007 staging system
- 3.1.2 Biopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cord
- 3.1.3 Direct laryngoscopy showing no evidence of greater than Stage II true glottic larynx cancer
- 3.1.4 PET/CT, X-ray, CT-scan of the chest showing no evidence of metastatic disease
- 3.1.5 PET/CT or CT-scan of the neck showing no evidence of nodal involvement
- 3.1.6 Age ≥ 18 years.
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- 3.1.7 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 3.1.7.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- 3.1.8 Ability to understand and the willingness to sign a written informed consent
- 3.1.9 Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 3.1.10 Negative Urine β-HCG or negative serum quantitative β-HCG or within 2 weeks prior to registration for women of childbearing potential
Who cannot join
- 3.2.1 Evidence of fixed vocal cord (Stage cT3)
- 3.2.2 Evidence of thyroid or soft tissue invasion (Stage cT4)
- 3.2.3 Evidence of positive nodal disease (Stage N1)
- 3.2.4 Evidence of metastatic disease (Stage M1)
- 3.2.5 Subjects may not be receiving any other investigational agents.
- 3.2.6 Non-squamous histology including lymphoma, neuroendocrine carcinoma, adenocarcinoma, or other histology.
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- 3.2.7 Previous laryngeal surgery.
- 3.2.8 Previous laser therapy within one year prior to protocol treatment.
- 3.2.9 Previous head and neck radiation therapy involving the glottic larynx
- 3.2.10 Patients with collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
- 3.2.11 Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed larynx cancer prior to registration.
- 3.2.12 History of another active uncontrolled malignancy at the time of study enrollment
- 3.2.13 Subjects must not be pregnant due to the potential for congenital abnormalities.
- 3.2.14 Patients smoking in excess of 2 packs of cigarettes per day.
- 3.2.15 ECOG performance status ≥ 2
- 3.2.16 Life expectancy < 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Texas Southwestern Medical Center
Dallas, Texas, 75239
About this study
Official title: A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose fraction reduction study.
Read the detailed description
Patients enrolled at each dose level will undergo routine evaluations to identify potential toxicities as well functional voice analyses. Adequate waiting periods will be used to ensure that fraction reduction does not proceed prior to observing toxicity. The purpose of the study will be either to determine the maximal fraction reduction possible until a dose is reached where a dose-limiting toxicity occurs. The initial dose and fractionation will be 50 Gy in 15 fractions with the goal to reduce number of fractions to a dose of 42.5 Gy in 5 fractions. The rationale for using 5 fractions is that it is tolerated in centrally located lung tumors at a dose of 50 Gy in 5 fractions, and thus, is likely to be tolerated in large calliber airways.
- Conditions
- Early-stage Glottic Larynx Cancer
- Being tested
- CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
- Keywords
- Larynx Cancer
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife Accelerated Hemilarynx Stereotactic RadiotherapyRadiation
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Receives: Radiation: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction
To determine the feasibility of fraction reduction for early-stage laryngeal cancer without exceeding the maximum tolerated dose.
Measured: 90 days
Secondary outcomes (6)
overall survival
To determine overall survival at 5 years
Measured: 5 years
loco-regional control
To determine loco-regional control at 5 years as determined by physical exam, visualization of tumor by layngoscopy, and CT-scan of the neck to determine if the primary tumor is controlled. A tissue biopsy or recurrent or persistent disease will be required to be considered a loco-regional failure.
Measured: 5 years
functional voice quality
To characterize functional voice quality of patients treated on this protocol.
Measured: 18 months
Quality of Life
To characterize the HR-QoL and PRO of patients treated on this protocol.
Measured: 18 months
cost-effectiveness
To determine cost-effectiveness of hypofractionated larynx irradiation
Measured: 18 months
late toxicity
To determine late toxicity as defined as treatment-related toxicity occurring ≥ 18 months from completion of radiation therapy.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start18 Nov 2013
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early-stage Glottic Larynx CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baran Sumer, University of Texas Southwestern Medical Center
- Investigators
- Baran Sumer, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984502
- Sponsor's protocol ID
- STU 062013-052
- Status last verified
- Jun 2022
- First submitted
- 7 Nov 2013
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Y, Chiu T, Dubas J, Tian Z, Lee P, Gu X, Yan Y, Sher D, Timmerman R, Zhao B. Benchmarking techniques for stereotactic body radiotherapy for early-stage glottic laryngeal cancer: LINAC-based non-coplanar VMAT vs. Cyberknife planning. Radiat Oncol. 2019 Nov 4;14(1):193. doi: 10.1186/s13014-019-1404-z.
PubMed 31684993Schwartz DL, Sosa A, Chun SG, Ding C, Xie XJ, Nedzi LA, Timmerman RD, Sumer BD. SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial. PLoS One. 2017 Mar 2;12(3):e0172055. doi: 10.1371/journal.pone.0172055. eCollection 2017.
PubMed 28253270
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
- ClinicalTrials.gov ID
- NCT01984502
- Acronym / sponsor ID
- STU 062013-052
- Conditions
- Early-stage Glottic Larynx Cancer
- Keywords
- Larynx Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 14 Nov 2013 (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 feasibility of reducing fractions in early-stage laryngeal cancer has not previously been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose fraction reduction study.
Detailed description
Patients enrolled at each dose level will undergo routine evaluations to identify potential toxicities as well functional voice analyses. Adequate waiting periods will be used to ensure that fraction reduction does not proceed prior to observing toxicity. The purpose of the study will be either to determine the maximal fraction reduction possible until a dose is reached where a dose-limiting toxicity occurs. The initial dose and fractionation will be 50 Gy in 15 fractions with the goal to reduce number of fractions to a dose of 42.5 Gy in 5 fractions. The rationale for using 5 fractions is that it is tolerated in centrally located lung tumors at a dose of 50 Gy in 5 fractions, and thus, is likely to be tolerated in large calliber airways.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: CyberKnife Accelerated Hemilarynx Stereotactic RadiotherapyCyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 3.1.1 Stage Tis, T1, or T2 laryngeal squamous cancer as defined by American Joint Commission on Cancer (AJCC) 2007 staging system
- 3.1.2 Biopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cord
- 3.1.3 Direct laryngoscopy showing no evidence of greater than Stage II true glottic larynx cancer
- 3.1.4 PET/CT, X-ray, CT-scan of the chest showing no evidence of metastatic disease
- 3.1.5 PET/CT or CT-scan of the neck showing no evidence of nodal involvement
Key exclusion criteria (16 listed)
- 3.2.1 Evidence of fixed vocal cord (Stage cT3)
- 3.2.2 Evidence of thyroid or soft tissue invasion (Stage cT4)
- 3.2.3 Evidence of positive nodal disease (Stage N1)
- 3.2.4 Evidence of metastatic disease (Stage M1)
- 3.2.5 Subjects may not be receiving any other investigational agents.
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 |
|---|---|---|
| CyberKnife Accelerated Hemilarynx Stereotactic RadiotherapyCyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy | Radiation | Radiation |
Primary outcome
Fraction
Time frame: 90 days
To determine the feasibility of fraction reduction for early-stage laryngeal cancer without exceeding the maximum tolerated dose.
6 secondary outcomes
overall survival
Time frame: 5 years
loco-regional control
Time frame: 5 years
functional voice quality
Time frame: 18 months
Quality of Life
Time frame: 18 months
cost-effectiveness
Time frame: 18 months
late toxicity
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 31684993Zhang Y, Chiu T, Dubas J, Tian Z, Lee P, Gu X, Yan Y, Sher D, Timmerman R, Zhao B. Benchmarking techniques for stereotactic body radiotherapy for early-stage glottic laryngeal cancer: LINAC-based non-coplanar VMAT vs. Cyberknife planning. Radiat Oncol. 2019 Nov 4;14(1):193. doi: 10.1186/s13014-019-1404-z.
- Derived from this study: PubMed 28253270Schwartz DL, Sosa A, Chun SG, Ding C, Xie XJ, Nedzi LA, Timmerman RD, Sumer BD. SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial. PLoS One. 2017 Mar 2;12(3):e0172055. doi: 10.1371/journal.pone.0172055. eCollection 2017.
Related trials for Early-stage Glottic Larynx Cancer
Not yet recruitingPhase 2
Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation Therapy for Early-Stage Glottic Cancer
Glottic Carcinoma
Recruiting
Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer
Laryngeal Neoplasm, Glottic Carcinoma
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.
Baran Sumer, MD principal investigator
UTSW
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 CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy in people with Early-stage Glottic Larynx Cancer, run by University of Texas Southwestern Medical Center 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 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: finished, as of the sponsor's last update on 30 Jun 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fraction (time frame: 90 days). 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 NCT01984502, which also lists 2 linked publications.
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 30 Jun 2022.