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

Who is this study for? Patients with Malignant Neoplasms of Respiratory and Intrathoracic Organs
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Radiation
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Jack Phan, MD, PHD
jphan@mdanderson.org
713-563-2300
Time Frame
Start Date: 2017-08-09
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 11
Treatments
Experimental: Stereotactic Hypofractionated Radioablation (HYDRA)
Participants receive HYDRA radiation on up to 5 days over the course of about 2 weeks, and for a total of 5 times.~Questionnaires completed at Baseline, on days receiving HYDRA, 6 weeks after last dose of HYDRA, 3 months after last dose of HYDRA, and 6 months after last dose of HYDRA. Also after the 6 month follow-up visit, every 3 months for the first 2 years, and then every 6 months after that for up to 5 years.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Cancer Prevention Research Institute of Texas

This content was sourced from clinicaltrials.gov

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