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NCT02633540 · REGISTRY CONDITION SEARCH

Investigation of Contralateral Arytenoid Sparing IMRT for T1a & T2a Larynx Cancer & Analysis of Post-treatment Laryngeal Function

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2021-03-09

The aim of this study is to define a new treatment technique for T1a larynx cancer that maintains excellent local control with less extensive radiation fields. It is thought that this will lead to patients having fewer changes to their voice and a higher quality of life after treatment when compared to the current standard treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Voice Quality (Voice Handicap Index)

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outcome · POSTED

Patient-reported Swallowing Satisfaction

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outcome · POSTED

Clinician Evaluation of Swallowing Function

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
* Inclusion Criteria: * Patients with T1a or T2a squamous cell carcinoma of the glottic larynx (tumor limited to one vocal cord with normal cord mobility). * Patients must be able to read and write English to comply with the questionnaire portions of the protocol. * ECOG performance status of 0 or 1. * Exclusion Criteria: * Patients with verrucous or adenocarcinoma * Patients with T1 tumors on both cords (T1b) * Patients with T2b-T4 true larynx tumors * Patients with primary supraglottic tumors that involve the true larynx * Patients with a prior or concurrent malignancy (other than nonmelanoma skin cancer or carcinoma in-situ of the cervix) are ineligible unless the previous cancer was treated 5 years or more prior to the current tumor and the patient has remained continually disease free * Patients who have received prior radiation to the head and neck * Pregnant or breastfeeding women
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All subjects will be treated using IMRT with the standard fractionation for T1a glottic cancer at Fox Chase Cancer Center: 63 Gy in 28 fractions; 6 for T1a and 65.25 Gy in 29 fractions; 33 for T2a. Treatment will be followed by functional assessments performed at months 1,3,6,12,and 24.
    intervention Names
    1. Radiation: IMRT Radiation
    label
    IMRT Radiation
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. IMRT Radiation
    description
    Radiation to Larynx
    name
    IMRT Radiation
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Demonstrate a 50% improvement in the VHI (voice handicap index) score at 24 months after the completion of therapy IMRT for T1a/T2a larynx cancer
    measure
    Voice Quality (Voice Handicap Index)
    time Frame
    24 Months
secondary Outcomes
  1. description
    Evaluate patient-reported satisfaction with swallowing at up to 24 months after the completion of radiation using the Eating Assessment Tool (EAT-10) questionnaire.
    measure
    Patient-reported Swallowing Satisfaction
    time Frame
    24 Months
  2. description
    Evaluate clinician-reported measure of swallowing 24 months after the completion of radiation as measured by fiberoptic endoscopic evaluation of swallowing (FEES) using the penetration, aspiration scale (PAS) scores for 3 commonly evaluated textures (cookie, puree, thin).
    measure
    Clinician Evaluation of Swallowing Function
    time Frame
    24 Months
Full study description
brief Summary
The aim of this study is to define a new treatment technique for T1a larynx cancer that maintains excellent local control with less extensive radiation fields. It is thought that this will lead to patients having fewer changes to their voice and a higher quality of life after treatment when compared to the current standard treatment.
detailed Description
Parallel opposed portal external beam radiation is the standard nonsurgical treatment for T1-2N0 glottic cancer. This technique involves treatment of the entire larynx for tumors that are small and limited. Although technological advances now allow radiation oncologists selectively to target and avoid adjacent sub-portions of any organ, these tools have not been applied T1-2N0 glottic cancer due to the perceived low toxicity of standard therapy. However, radiotherapy for early glottic cancer is not without functional side effects and it is not known whether post-treatment function after whole larynx radiation is superior to a more targeted surgical approach. This is a phase II study to treat unilateral glottic cancer (Stage T1a and T2aN0) with intensity modulated radiation therapy (IMRT). In view of the anticipated small volume of disease at presentation and need to limit the potential for a "marginal miss", treatment will include the entire involved vocal fold, anterior commissure, and the anterior 1/3 of the contralateral vocal fold thus sparing the contralateral arytenoid cartilage and musculature ("contralateral arytenoid sparing IMRT"). In addition, we propose to perform sophisticated objective and patient reported measures regarding speech outcomes for two years after the completion of therapy at specified intervals, to better gain an understanding of the effects of therapy. Our findings will have the potential to dramatically advance the field of early larynx cancer therapy by demonstrating the efficacy of limiting the volume of uninvolved larynx that receives radiation and comprehensively assessing the functional outcomes of said therapy.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      payload
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      true
      id
      nct-edge-877ed479e1f11500ce8d
      link basis
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT02633540
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
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      source json pointer
      /studies/23/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice