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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01984502
First received: November 7, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Early-stage Glottic Larynx Cancer
Radiation: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

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


Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To determine overall survival at 5 years

  • loco-regional control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • functional voice quality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To characterize functional voice quality of patients treated on this protocol.

  • Quality of Life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To characterize the HR-QoL and PRO of patients treated on this protocol.

  • cost-effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To determine cost-effectiveness of hypofractionated larynx irradiation

  • late toxicity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To determine late toxicity as defined as treatment-related toxicity occurring ≥ 18 months from completion of radiation therapy.


Estimated Enrollment: 33
Study Start Date: November 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
Radiation: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
Other Name: CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

3.1.6.1 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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984502

Contacts
Contact: Baran Sumer, MD 214-633-1753
Contact: Susie Chen, MD 214-645-8525

Locations
United States, Texas
University Of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75239
Contact: Susie Chen, MD    214-645-8525      
Sub-Investigator: Susie Chen, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Baran Sumer, MD UTSW
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01984502     History of Changes
Other Study ID Numbers: STU 062013-052
Study First Received: November 7, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014