Trial Outcomes & Findings for Investigation of Contralateral Arytenoid Sparing IMRT for T1a & T2a Larynx Cancer & Analysis of Post-treatment Laryngeal Function (NCT NCT02633540)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

24 Months

Results posted on

2021-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	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. IMRT Radiation: Radiation to Larynx
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT Radiation n=2 Participants 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
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=2 Participants
Age, Categorical >=65 years	1 Participants n=2 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 21 • n=2 Participants
Sex: Female, Male Female	1 Participants n=2 Participants
Sex: Female, Male Male	1 Participants n=2 Participants
Region of Enrollment United States	2 participants n=2 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Number of patients enrolled is too small for meaningful analysis

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Population: Number of patients enrolled is too small for meaningful analysis

Evaluate patient-reported satisfaction with swallowing at up to 24 months after the completion of radiation using the Eating Assessment Tool (EAT-10) questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Population: Number of patients enrolled is too small for meaningful analysis

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).

Outcome measures

Outcome data not reported

Adverse Events

IMRT Radiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Galloway

Fox Chase Cancer Center

Phone: 215-728-5536

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place