Comparing hypofractionated and conventional radiotherapy for laryngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intraoperative Methadone for Postoperative Pain in Head and Neck Cancer Patients

  This trial tests whether giving methadone during surgery, in addition to standard fentanyl, helps control pain after head and neck cancer surgery more effectively than fentanyl alone.

  Recruiting Phase 4 OHSU Knight Cancer Institute · Portland, Oregon · NCT07857655

• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

  This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.

  Recruiting Phase 1 Erasmus Medical Center · Rotterdam, South Holland · NCT07690618

• Telemedicine follow-up for early laryngeal cancer patients

  This study tests if follow-up care through Telemedicine is just as good as in-person visits for people with early laryngeal cancer, especially for those who live far from treatment centers.

  Recruiting University Medical Center Groningen · Groningen, Provincie Groningen · NCT06940505

• Intralesional Cisplatin + Epinephrine for Recurrent Laryngeal SCC

  This study tests injecting chemotherapy with epinephrine directly into recurrent laryngeal squamous cell carcinoma in adults who have already had radiation.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT07392580

• Personalized compartment-sparing postoperative radiation for head and neck cancer

  This trial tests whether targeted, compartment-sparing postoperative radiation can reduce side effects while keeping cancer control for people with surgically treated head and neck squamous cell carcinoma.

  Recruiting at 3 sites Phase 2 Insel Gruppe AG, University Hospital Bern · Basel and 2 other locations · NCT07058805

• Cemiplimab with or without CDX-1140 given before surgery for stage III-IV head and neck cancer

  This trial tests whether adding the immune stimulant CDX-1140 to cemiplimab before surgery helps shrink tumors in people with resectable stage III-IV head and neck squamous cell carcinoma.

  Recruiting at 12 sites Phase 2 National Cancer Institute (NCI) · Irvine, California and 11 other locations · NCT06980038

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.