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Trial record 7 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngeal Neoplasms"

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

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ClinicalTrials.gov Identifier: NCT03548285
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Glottic Carcinoma Radiation: Radiation therapy Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: patient with low risk

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)

Radiation: Radiation therapy
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)

Experimental: patient with moderate risk

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)

Radiation: Radiation therapy
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)




Primary Outcome Measures :
  1. Number of patients with local failure following SABR treatment of early glottic larynx cancers [ Time Frame: 2 years ]
    Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.


Secondary Outcome Measures :
  1. Voice-quality score following treatment with SABR. [ Time Frame: Baseline and 1, 3, 6, 12, 18, 24 months after treatment ]

    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


  2. Swallowing ability following treatment with SABR. [ Time Frame: Baseline and 1, 3, 6, 12, 18, 24 months after treatment ]

    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


  3. Number of patients with grade 3-5 acute and late toxicities following treatment with SABR [ Time Frame: 90 days, 3 years ]
    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.

  4. Health-related quality of life following treatment with SABR. [ Time Frame: Baseline and 6, 12, 24 months after treatment ]

    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


  5. Cumulative incidence of locoregional failure following SABR [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  1. AJCC stage III or stage IV larynx cancer
  2. Involvement of the arytenoid cartilage beyond the vocal process.
  3. Previous treatment (e.g. cold knife excision, laser treatment) of the proposed radiation treatment volume, where the intent of treatment was specifically for therapeutic purpose, rather than for biopsy/ tissue diagnosis.
  4. Prior chemotherapy for treatment of the targeted larynx lesion
  5. Synchronous primaries in the head and neck
  6. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  7. Subjects smoking in excess of 1 pack of cigarettes per day.
  8. Subjects may not be receiving any other investigational agents.
  9. 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.
  10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

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 ClinicalTrials.gov identifier (NCT number): NCT03548285


Contacts
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Contact: David Sher, MD 214-645-7607 david.sher@utsouthwestern.edu
Contact: Sarmistha Sen 214-645-1477 sarmistha.sen@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David Sher, MD    214-645-8525    david.sher@utsouthwestern.edu   
Contact: Sarmistha Sen    214-648-1477    sarmistha.sen@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: David Sher, MD University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03548285     History of Changes
Other Study ID Numbers: STU 122017-043
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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