Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer (NCT03114462) | Clinical Trial Compass
RecruitingPhase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
United States11 participantsStarted 2017-08-09
Plain-language summary
To find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The safety of this radiation will also be studied.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
✓. Stage T1N1/T2-4aN0-1 disease, as defined by American Joint Committee on Cancer (AJCC) criteria.
✓. ECOG (Zubrod) performance status 0-2.
✓. 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.
✓. 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 English language and the willingness to sign a written informed consent.
Exclusion criteria
✕. Patients who have undergone resection of primary disease.
✕. Patients who have received induction chemotherapy for their cancer diagnosis.
What they're measuring
1
Maximum Tolerated Dose (MTD) of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
✕. 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.
✕. Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
✕. Prior radiation therapy to the head and neck region.
✕. 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.
✕. Patients unable or unwilling to give written, informed consent.
✕. 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.