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

• Sponsor: Fox Chase Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02633540
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 29.5
• Patients Per Site Per Month: 0.1

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• 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: Nov 16, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Voice Quality (Voice Handicap Index) [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 [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111

Sponsors and Collaborators

• Fox Chase Cancer Center

Investigators

• Principal Investigator: Thomas Galloway, MD, Fox Chase Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 31, 2017

More Information

Publications

None provided.

• Responsible Party: Fox Chase Cancer Center
• ClinicalTrials.gov Identifier: NCT02633540
• Other Study ID Numbers: RT-083; 15-1014
• First Posted: Dec 17, 2015
• Last Update Posted: Mar 9, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Fox Chase Cancer Center: T1a Larynx Cancer; T2a Larynx Cancer
• Additional relevant MeSH terms: Laryngeal Neoplasms

Study Results

Participant Flow

Arm/Group Title	IMRT Radiation
Arm/Group 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. IMRT Radiation: Radiation to Larynx
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	IMRT Radiation
Arm/Group 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. IMRT Radiation: Radiation to Larynx
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	48.5 (21)
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Voice Quality (Voice Handicap Index)
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
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Number of patients enrolled is too small for meaningful analysis

Arm/Group Title	IMRT Radiation
Arm/Group 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. IMRT Radiation: Radiation to Larynx
Measure Participants	0

2. Secondary Outcome

Title	Patient-reported Swallowing Satisfaction
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.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Number of patients enrolled is too small for meaningful analysis

Arm/Group Title	IMRT Radiation
Arm/Group 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. IMRT Radiation: Radiation to Larynx
Measure Participants	0

3. Secondary Outcome

Title	Clinician Evaluation of Swallowing Function
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).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Number of patients enrolled is too small for meaningful analysis

Arm/Group Title	IMRT Radiation
Arm/Group 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. IMRT Radiation: Radiation to Larynx
Measure Participants	0

Adverse Events

Time Frame	24 months
Arm/Group Title	IMRT Radiation
Arm/Group 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. IMRT Radiation: Radiation to Larynx
All Cause Mortality
	IMRT Radiation
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	IMRT Radiation
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	IMRT Radiation
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.