CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01984502
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : May 7, 2018
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Early-stage Glottic Larynx Cancer Radiation: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
Actual Study Start Date : November 18, 2013
Actual Primary Completion Date : June 2, 2017
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Radiation
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
Radiation: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy

Primary Outcome Measures :
  1. Fraction [ Time Frame: 90 days ]
    To determine the feasibility of fraction reduction for early-stage laryngeal cancer without exceeding the maximum tolerated dose.

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    To determine overall survival at 5 years

  2. loco-regional control [ Time Frame: 5 years ]
    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.

  3. functional voice quality [ Time Frame: 18 months ]
    To characterize functional voice quality of patients treated on this protocol.

  4. Quality of Life [ Time Frame: 18 months ]
    To characterize the HR-QoL and PRO of patients treated on this protocol.

  5. cost-effectiveness [ Time Frame: 18 months ]
    To determine cost-effectiveness of hypofractionated larynx irradiation

  6. late toxicity [ Time Frame: 18 months ]
    To determine late toxicity as defined as treatment-related toxicity occurring ≥ 18 months from completion of radiation therapy.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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 Chest X-ray or CT-scan showing no evidence of metastatic disease 3.1.5 CT-scan of the neck showing no evidence of nodal involvement 3.1.6 Age ≥ 18 years. 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. 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

Exclusion Criteria:

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.

3.2.7 Previous laryngeal surgery or laser therapy 3.2.8 Previous head and neck radiation therapy involving the glottic larynx 3.2.9 Previous head and neck malignancy other than superficial basal cell or squamous cell carcinoma 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 uncontrolled malignancy other than superficial basal cell carcinoma or squamous cell carcinoma of skin diagnosed within the past 3 years 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01984502

United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75239
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Baran Sumer, MD UTSW

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT01984502     History of Changes
Other Study ID Numbers: STU 062013-052
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by University of Texas Southwestern Medical Center:
Larynx Cancer

Additional relevant MeSH terms:
Laryngeal Diseases
Laryngeal Neoplasms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms