HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer

Stopped early · Phase 1

Conditions studied: Squamous Cell Carcinoma of the Larynx

In brief

single-modality phase I dose escalation toxicity study for first-line curative treatment of head and neck squamous cell carcinoma.

Key facts

Study ID

NCT02464137

Run by

University of Texas Southwestern Medical Center

People needed

15

Starts

2015-04-27

Expected to finish

2019-03-04

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
• Stage T1-2N1-2c/T3-4N0-2c 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.
• 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.
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if…

• Patients who have undergone resection of primary disease.
• Patients who have received induction chemotherapy for their cancer diagnosis.
• 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:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
• Transmural myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
• 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.
• History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• Evidence of metastatic disease

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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