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

NCT02633540 | Terminated Phase 2 Results DMC

• 2 other identifiers: RT-08315-1014
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Neoplasms

Keywords

T1a Larynx Cancer; T2a Larynx Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient-reported Swallowing Satisfaction

  24 Months

• Clinician Evaluation of Swallowing Function

  24 Months

Study Arms (1)

IMRT Radiation

EXPERIMENTAL

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

Interventions

IMRT Radiation RADIATION

Radiation to Larynx

IMRT Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr. Thomas Galloway
• Organization: Fox Chase Cancer Center

Thomas.Galloway@fccc.edu

215-728-5536

Study Officials

• Thomas Galloway, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: November 16, 2015
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: March 9, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-02

Locations

US (1)