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

Conditions

• Malignant Neoplasms of Respiratory and Intrathoracic Organs
• Squamous Cell Carcinoma of the Larynx

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Hypofractionated Radioablation — RADIATION
  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.
• Questionnaires — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Aug 9, 2017

Status verified

Apr 2026

Primary completion

Jun 1, 2027

Completion

Jun 1, 2027

Study Design

Enrollment

11 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

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

Central Contacts

• Jack Phan, MD, PHD
  713-563-2300
  [email protected]

Locations (1)

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