A Phase 2 interventional study of IMRT Radiation in Laryngeal Neoplasms, sponsored by Fox Chase Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Fox Chase Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
244 studies on the registry are indexed under Laryngeal Neoplasms; 63 are open to participants now.
This study's enrollment of 2 is below the median of 44 across 181 interventional studies indexed under Laryngeal Neoplasms.
Browse Laryngeal Neoplasms studies →Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with T1a or T2a squamous cell carcinoma of the glottic larynx (tumor limited to one vocal cord with normal cord mobility).
Patients with verrucous or adenocarcinoma
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
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
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
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
| Milestone | IMRT Radiation |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
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
No measurements were reported for this outcome.
Evaluate patient-reported satisfaction with swallowing at up to 24 months after the completion of radiation using the Eating Assessment Tool (EAT-10) questionnaire.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IMRT Radiation | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | IMRT Radiation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 1 |
| Age, Continuous(years) | IMRT Radiation |
|---|---|
| Median | 48.5 ± 21 |
| Sex: Female, Male(Participants) | IMRT Radiation |
|---|---|
| Female | 1 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | IMRT Radiation |
|---|
| Region of Enrollment(participants) | IMRT Radiation |
|---|---|
| United States | 2 |
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This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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