Treatment of laryngeal cancer using advanced radiation techniques

A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer

This study is testing a new type of focused radiation treatment for people with laryngeal cancer to see how much they can safely receive.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 11 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT03114462 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) for patients with squamous cell carcinoma of the larynx. Participants will be assigned to different dose levels of HYDRA radiation, with up to 10 patients enrolled at each level. The study will assess safety and tolerability, with participants receiving radiation over a period of about two weeks. The trial will involve precise positioning using CT or PET-CT scans to ensure accurate treatment delivery.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with histologically confirmed squamous cell carcinoma of the larynx at specific stages.

Not a fit: Patients with advanced laryngeal cancer beyond the specified stages or those unable to tolerate radiation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for patients with laryngeal cancer.

How similar studies have performed: Other studies using stereotactic radiation techniques have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
2. Stage T1N1/T2-4aN0-1 disease, as defined by American Joint Committee on Cancer (AJCC) criteria.
3. ECOG (Zubrod) performance status 0-2.
4. Must be functionally and technically fit for partial laryngectomy. Subsite study candidates will be evaluated by enrolling physician. The assessment checklist will be submitted at time of enrollment and evaluated by Dr. Gross or Dr. Phan.
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.
6. 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).
7. Ability to understand English language and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Patients who have undergone resection of primary disease.
2. Patients who have received induction chemotherapy for their cancer diagnosis.
3. Patients who have undergone a diverting tracheostomy which is either a) traversing directly through tumor, b) has been placed for true airway insufficiency. Patients with a tracheostomy placed preemptively for impending airway compromise remain eligible for enrollment.
4. Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
5. Prior radiation therapy to the head and neck region.
6. Women of childbearing potential (a woman of child-bearing potential is a reproductively mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
7. Patients unable or unwilling to give written, informed consent.
8. Severe, active co-morbidity, defined as follows: a. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. b. Transmural myocardial infarction within the last 6 months. c. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. d. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration. e. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and f. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. Protocol-specific requirements may also exclude immuno-compromised patients.
9. Exclusion #8 continued: g. History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.
10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
11. Evidence of metastatic disease

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Jack Phan, MD, PHD — M.D. Anderson Cancer Center
• Study coordinator: Jack Phan, MD, PHD

Conditions: Malignant Neoplasms of Respiratory and Intrathoracic Organs, Squamous Cell Carcinoma of the Larynx, Malignant neoplasms of respiratory and intrathoracic organs, Squamous cell carcinoma of the larynx, Stereotactic hypofractionated radioablation, HYDRA, Questionnaires, Surveys