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

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: NCT02633540
Recruitment Status : Terminated (Slow accrual)
First Posted : December 17, 2015
Last Update Posted : June 15, 2018
Information provided by (Responsible Party):
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment Phase
Laryngeal Neoplasms Radiation: IMRT Radiation Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Investigation of Contralateral Arytenoid Sparing IMRT for T1a and T2a Larynx Cancer With Detailed Analysis of Post-treatment Laryngeal Function
Actual Study Start Date : November 16, 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: IMRT Radiation
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.
Radiation: IMRT Radiation
Radiation to Larynx

Primary Outcome Measures :
  1. Voice Quality (voice handicap index) [ Time Frame: 24 Months ]
    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

Secondary Outcome Measures :
  1. Patient-reported Swallowing Satisfaction [ Time Frame: 24 Months ]
    Evaluate patient-reported satisfaction with swallowing at up to 24 months after the completion of radiation using the Eating Assessment Tool (EAT-10) questionnaire.

  2. Clinician Evaluation of Swallowing Function [ Time Frame: 24 Months ]
    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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

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): NCT02633540

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Principal Investigator: Thomas Galloway, MD Fox Chase Cancer Center

Responsible Party: Fox Chase Cancer Center Identifier: NCT02633540     History of Changes
Other Study ID Numbers: RT-083
15-1014 ( Other Identifier: Fox Chase Cancer Center IRB )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Keywords provided by Fox Chase Cancer Center:
T1a Larynx Cancer
T2a Larynx Cancer

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