Clinical Trial: Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: The goal of this clinical research study is 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.

Detailed Summary:

Study Groups:

If participant is found to be eligible to take part in this study, participant will be assigned to a radiation level of HYDRA radiation based on when participant joins this study. Up to 5 dose levels of HYDRA radiation will be tested. Up to 10 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HYDRA radiation is found.

HYDRA Radiation Administration:

If participant is found to be eligible to take part in this study, participant will receive HYDRA radiation on up to 5 days over the course of about 2 weeks.

During radiation, participant will be asked to lie still for about 30-45 minutes. To help make sure that participant's head and neck do not move, participant will wear a head and neck mask. Participant will then have CT or PET-CT scans to make sure that participant is in the right position before participant begins HYDRA radiation. The actual HYDRA radiation treatment will take about 5-10 minutes to complete.

Length of Study Participation:

Participant may continue receiving HYDRA radiation for up to 2 weeks and for a total of 5 times. Participant will no longer be able to receive the study radiation if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on this study will be over after Long-Term Follow-Up. Long-Term Follow-Up may take up to 10 years.

Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Maximum Tolerated Dose (MTD) of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment [ Time Frame: 180 days ]

Toxicity graded using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.0.


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall Complete Response Rate of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment [ Time Frame: 10 years ]

Overall complete response rate with laryngeal HYDRA measured from duration of time from start of treatment to primary disease relapse.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 11, 2017
Date Started: June 2017
Date Completion: June 2027
Last Updated: April 19, 2017
Last Verified: April 2017