Laryngeal Neoplasms
Conditions
Keywords
T1a Larynx Cancer, T2a Larynx Cancer
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.
Interventions
RADIATIONIMRT Radiation
Radiation to Larynx
Sponsors
Fox Chase Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | IMRT Radiation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | — |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 21 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 2 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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
Time frame: 24 Months
Population: Number of patients enrolled is too small for meaningful analysis
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).
Time frame: 24 Months
Population: Number of patients enrolled is too small for meaningful analysis
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.
Time frame: 24 Months
Population: Number of patients enrolled is too small for meaningful analysis