Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

NCT ID: NCT06080503

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2029-03-14

Brief Summary

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

Detailed Description

Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.

All screening procedures must be performed within 30 days prior to registration into the study unless otherwise stated. The screening procedures include:

Informed Consent Medical history--Complete medical and surgical history Demographics--Age, gender, race, ethnicity Review subject eligibility criteria Review previous and concomitant medications Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure), height, weight Performance status--Performance status evaluated prior to study entry. If there is any variability in the physicians' notes, the higher number will be used for research purposes.

Positron emission tomography-computerized tomography or computerized tomography of neck (any time prior to registration) Laryngoscopy Pregnancy test (for females of child-bearing potential) Quality of life Questionnaires and Symptom Questionnaires --EORTC QLQ-C30, H&N 35, VHI, and EQ-5D. These forms will be referred to collectively as QoL Questionnaires. Can be given on paper, over the phone, or in EPIC as needed.

Procedures During Treatment Day 1-First fraction of radiotherapy per standard, departmental stereotactic protocol

Follow-up Procedures--After initial follow-up at 2 weeks (+/- 7 days) after completion of radiation therapy, subjects will be followed at 3 months and 12 months. These protocol mandated procedures will occur at each follow-up:

Interim history Physical exam, vital signs, ECOG Performance Status Laryngoscopy (optional at 1-2 weeks) to assess tumor response and toxicity Quality of life and voice quality assessment. Can be given on paper, over the phone, or in EPIC as needed.

Conditions

Laryngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Highly conformal hypofractionated radiotherapy

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

Group Type: EXPERIMENTAL

LT-SABR

Intervention Type: RADIATION

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

Conventional radiotherapy

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

Group Type: EXPERIMENTAL

IMRT

Intervention Type: RADIATION

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

Interventions

LT-SABR

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

Intervention Type: RADIATION

IMRT

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Minimum age is 18 years.

4. ECOG Performance Status 0-2

5. 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.

5.1 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).

6. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

1. AJCC stage III or stage IV larynx cancer

2. Involvement of the arytenoid cartilage beyond the vocal process.

3. Prior chemotherapy for treatment of the targeted larynx lesion.

4. Synchronous primaries in the head and neck

5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.

6. Subjects smoking in excess of 1 pack of cigarettes per day.

7. Subjects may not be receiving any other investigational agents.

8. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Sher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Sher, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David J Sher, MD,MPH

Role: CONTACT

David.Sher@UTSouthwestern.edu

214-645-2465

Sarah Neufeld

Role: CONTACT

sarah.hardee@utsouthwestern.edu

214-645-8525

Facility Contacts

Sarah Neufeld

Role: primary

Sarah.hardee@utsouthwestern.edu

214-645-8525

Liliana Robles

Role: backup

Liliana.Robles@utsouthwestern.edu

214-645-8525

Other Identifiers

2023-0715

Identifier Type: -

Identifier Source: org_study_id