Comparing hypofractionated and conventional radiotherapy for laryngeal cancer
G-FORCE: Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus ConvEntional Radiotherapy
This study is testing whether a new type of shorter radiation treatment is easier for people with laryngeal cancer to handle than the standard longer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06080503 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the acute tolerance of highly conformal hypofractionated radiotherapy against conventional radiotherapy in patients with laryngeal carcinoma. Participants will undergo a series of screening procedures to determine eligibility, including medical history assessments, physical exams, and imaging studies. The study will involve administering different radiotherapy techniques and evaluating their effects on patient tolerance and quality of life. Quality of life will be assessed using standardized questionnaires throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of early-stage squamous cell carcinoma of the glottic larynx.
Not a fit: Patients with advanced laryngeal cancer or those with significant comorbidities affecting treatment tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with laryngeal carcinoma, potentially enhancing their tolerance to radiotherapy.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy approaches, suggesting potential benefits in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Sher, MD, MPH — University of Texas Southwestern Medical Center
- Study coordinator: David J Sher, MD,MPH
- Email: David.Sher@UTSouthwestern.edu
- Phone: 214-645-2465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.