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

Laryngeal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02633540
• Other study ID #: RT-083
• Secondary ID: 15-1014
• Status: Terminated
• Phase: Phase 2
• Start date: November 16, 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2021
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Laryngeal Neoplasms

Intervention

Radiation:
• IMRT Radiation
Radiation to Larynx

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice Quality (Voice Handicap Index)	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	24 Months
Secondary	Patient-reported Swallowing Satisfaction	Evaluate patient-reported satisfaction with swallowing at up to 24 months after the completion of radiation using the Eating Assessment Tool (EAT-10) questionnaire.	24 Months
Secondary	Clinician Evaluation of Swallowing Function	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).	24 Months