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Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

Primary Purpose

Glottic Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation therapy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glottic Carcinoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
  2. Clinical stage I-II (American Joint Committee on Cancer AJCC, 7th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
  3. Age ≥ 18 years.
  4. ECOG Performance Status 0-2

  5. 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.

    5.1 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).
  6. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
  7. Ability to understand and the willingness to sign a written informed consent.
  8. Patients with cognitive impairment or other limited decision making capacity with the ability to understand and willingly sign written informed consent or have the consent signed by a designated legally authorized representative (LAR)

Exclusion Criteria:

  1. AJCC stage III or stage IV larynx cancer
  2. Involvement of the arytenoid cartilage beyond the vocal process.
  3. Prior chemotherapy for treatment of the targeted larynx lesion
  4. Synchronous primaries in the head and neck
  5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  6. Subjects smoking in excess of 1 pack of cigarettes per day.
  7. Subjects may not be receiving any other investigational agents.
  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patient with low risk

patient with moderate risk

Arm Description

Low-risk is defined by: Planning target volume (PTV) less than 10 cc, AND No reported smoking within 1 month from registration Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)

Moderate-risk is defined by: Planning target volume (PTV) greater than or equal to 10 cc, OR Smoking within 1 month from registration (no more than 1 pack per day) Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy)

Outcomes

Primary Outcome Measures

Number of patients with local failure following SABR treatment of early glottic larynx cancers
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.

Secondary Outcome Measures

Voice-quality score following treatment with SABR
Voice Handicap Index (VHI) voice-quality score to monitor changes in self-perception of voice handicap before and after treatment. 0-30 Mild Minimal amount of handicap 31-60 Moderate handicap 60-120 Severe handicap
Swallowing ability following treatment with SABR.
The M. D. Anderson Dysphagia Inventory (MDADI) to assess how patients view the outcome of their swallowing ability as a result of treatment and how this swallowing dysfunction affects their quality of life. MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). MDADI is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer
Number of patients with grade 3-5 acute and late toxicities following treatment with SABR
Number of patients with grade 3-5 acute (start of treatment through 90 days from the completion of treatment) and late (after 90 days from the completion of treatment) adverse events, according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria.
Health-related quality of life following treatment with SABR.
Average patient utilities (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment EuroQol five dimension scale (EQ-5D) is a standardized instrument for measuring generic health status. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems
Cumulative incidence of locoregional failure following SABR
Specifically, the 2-year cumulative risk of biopsy-proven recurrence anywhere in the larynx or neck following SABR. Recurrence in this context includes biopsy-proven cancer anywhere in the supraglottic, glottic, or subglottic larynx, as well as any malignant lymph node in the cervical or supraclavicular lymph nodes.
Overall survival
Overall survival
Cumulative incidence of regional failure and distant metastasis
With death and prior locoregional failure as competing risks
Laryngectomy-free survival
Laryngectomy-free survival probability at 2 years

Full Information

First Posted
May 3, 2018
Last Updated
February 13, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03548285
Brief Title
Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer
Official Title
A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of treatment with radiation therapy is to deliver as high of a dose as possible to the target (tumor), while minimizing the dose to the normal tissues where late-side effects can drastically affect patient quality of life.
Detailed Description
Radiation will be delivered twice per week for 5 fractions (42.5 Gy cohort, low-risk) or daily for 16 fractions (58.08 Gy cohort, moderate-risk). Low-risk is defined by: Planning target volume (PTV) less than 10 cc, AND No reported smoking within 1 month from registration Moderate-risk is defined by: Planning target volume (PTV) greater than or equal to 10 cc, OR Smoking within 1 month from registration (no more than 1 pack per day)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glottic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient with low risk
Arm Type
Experimental
Arm Description
Low-risk is defined by: Planning target volume (PTV) less than 10 cc, AND No reported smoking within 1 month from registration Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)
Arm Title
patient with moderate risk
Arm Type
Experimental
Arm Description
Moderate-risk is defined by: Planning target volume (PTV) greater than or equal to 10 cc, OR Smoking within 1 month from registration (no more than 1 pack per day) Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy)
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)
Primary Outcome Measure Information:
Title
Number of patients with local failure following SABR treatment of early glottic larynx cancers
Description
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Voice-quality score following treatment with SABR
Description
Voice Handicap Index (VHI) voice-quality score to monitor changes in self-perception of voice handicap before and after treatment. 0-30 Mild Minimal amount of handicap 31-60 Moderate handicap 60-120 Severe handicap
Time Frame
From baseline to 2 years post-treatment
Title
Swallowing ability following treatment with SABR.
Description
The M. D. Anderson Dysphagia Inventory (MDADI) to assess how patients view the outcome of their swallowing ability as a result of treatment and how this swallowing dysfunction affects their quality of life. MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). MDADI is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer
Time Frame
From baseline to 2 years post-treatment
Title
Number of patients with grade 3-5 acute and late toxicities following treatment with SABR
Description
Number of patients with grade 3-5 acute (start of treatment through 90 days from the completion of treatment) and late (after 90 days from the completion of treatment) adverse events, according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria.
Time Frame
90 days, 3 years
Title
Health-related quality of life following treatment with SABR.
Description
Average patient utilities (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment EuroQol five dimension scale (EQ-5D) is a standardized instrument for measuring generic health status. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems
Time Frame
From baseline to 2 years post-treatment
Title
Cumulative incidence of locoregional failure following SABR
Description
Specifically, the 2-year cumulative risk of biopsy-proven recurrence anywhere in the larynx or neck following SABR. Recurrence in this context includes biopsy-proven cancer anywhere in the supraglottic, glottic, or subglottic larynx, as well as any malignant lymph node in the cervical or supraclavicular lymph nodes.
Time Frame
2 years
Title
Overall survival
Description
Overall survival
Time Frame
2 years
Title
Cumulative incidence of regional failure and distant metastasis
Description
With death and prior locoregional failure as competing risks
Time Frame
2 years
Title
Laryngectomy-free survival
Description
Laryngectomy-free survival probability at 2 years
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx. Clinical stage I-II (American Joint Committee on Cancer AJCC, 7th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease. Age ≥ 18 years. ECOG Performance Status 0-2 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. 5.1 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). Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential. Ability to understand and the willingness to sign a written informed consent. Patients with cognitive impairment or other limited decision making capacity with the ability to understand and willingly sign written informed consent or have the consent signed by a designated legally authorized representative (LAR) Exclusion Criteria: AJCC stage III or stage IV larynx cancer Involvement of the arytenoid cartilage beyond the vocal process. Prior chemotherapy for treatment of the targeted larynx lesion Synchronous primaries in the head and neck Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. Subjects smoking in excess of 1 pack of cigarettes per day. Subjects may not be receiving any other investigational agents. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sher, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32890609
Citation
Zhao B, Park YK, Gu X, Reynolds R, Timmerman R, Sher DJ. Surface guided motion management in glottic larynx stereotactic body radiation therapy. Radiother Oncol. 2020 Dec;153:236-242. doi: 10.1016/j.radonc.2020.08.027. Epub 2020 Sep 3.
Results Reference
derived

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Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

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