Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

NCT06080503 | Recruiting DMC FDA Device

• 1 other identifier: 2023-0715
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.

Conditions

Laryngeal Carcinoma

Keywords

Larynx

Outcome Measures

Primary Outcomes (1)

• To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.

  Acute toxicity score (i.e. T score), defined as the mean number of grade 2 or higher acute toxicities experienced between the start of radiotherapy and 3 months following treatment.

  3 months following treatment

Study Arms (2)

Highly conformal hypofractionated radiotherapy

EXPERIMENTAL

LT-SABR 42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly

Radiation: LT-SABR

Conventional radiotherapy

EXPERIMENTAL

Conventional Radiotherapy 63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)

Radiation: IMRT

Interventions

LT-SABR RADIATION

42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly

Highly conformal hypofractionated radiotherapy

IMRT RADIATION

63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)

Conventional radiotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
• Clinical stage 0-II (AJCC, 8th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
• Minimum age is 18 years.
• ECOG Performance Status 0-2
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• AJCC stage III or stage IV larynx cancer
• Involvement of the arytenoid cartilage beyond the vocal process.
• Prior chemotherapy for treatment of the targeted larynx lesion.
• Synchronous primaries in the head and neck
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
• Subjects smoking in excess of 1 pack of cigarettes per day.
• Subjects may not be receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• David Sher, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Sher, MD,MPH

CONTACT

214-645-2465; David.Sher@UTSouthwestern.edu

Sarah Neufeld

CONTACT

214-645-8525; sarah.hardee@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: March 14, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 14, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)