Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
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|ClinicalTrials.gov Identifier: NCT03114462|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Respiratory and Intrathoracic Organs Squamous Cell Carcinoma of the Larynx||Radiation: Stereotactic Hypofractionated Radioablation Behavioral: Questionnaires||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer|
|Actual Study Start Date :||August 9, 2017|
|Estimated Primary Completion Date :||August 2027|
|Estimated Study Completion Date :||August 2028|
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.
Radiation: Stereotactic Hypofractionated Radioablation
Starting dose is 8.0 Gy per fraction for 5 fractions (total dose = 40.0 Gy). Subsequent cohorts of participants receive an additional 0.5 Gy per fraction.
Other Name: HYDRA
Quality of life and symptom 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.
Other Name: Surveys
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114462
|Contact: Jack Phan, MD, PHDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jack Phan, MD,PHD email@example.com|
|Principal Investigator:||Jack Phan, MD, PHD||M.D. Anderson Cancer Center|