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TerminatedNCT02464137HYDRAUpdated Aug 20, 2020

HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer

A Phase 1 interventional study of radiation in Squamous Cell Carcinoma of the Larynx, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by University of Texas Southwestern Medical Center · Phase 1, Interventional, and Treatment

Why this study was terminated
unexpected toxicities
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
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Study summary

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

Read the detailed description

HYDRA will consist of 5 fraction SBRT treatment targeting only grossly evident disease localized by examination and standard diagnostic CT, MR, and PET-CT imaging. Prophylactic coverage of uninvolved at-risk mucosal and nodal drainage basins will be strictly disallowed. The initial dose cohort will be treated to a total of 42.5 Gy in five equal fractions delivered every other day over a two week period (biologically equivalent to 66 Gy delivered in 2 Gy daily fractions), drawn from our successful institutional experience with similar dosing and fractionation for early-stage larynx SBRT. Escalation of total dose will proceed in 2.5 Gy increments, up to a final target dose of 50 Gy.

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Conditions studied

  • Squamous Cell Carcinoma of the Larynx
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In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's enrollment of 15 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
    2. Transmural myocardial infarction within the last 6 months.
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
    4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
    5. 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.
    6. 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.
    7. 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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Radiation

    Patients in each dose cohort will all be treated as a single group. The starting dose will be 8.5 Gy per fraction for 5 fractions (total dose = 42.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per fraction.

    Radiation: radiation

Interventions

  • Radiationradiation

    Patients in each dose cohort will all be treated as a single group. The starting dose will be 8.5 Gy per fraction for 5 fractions (total dose = 42.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per fraction.

    Also known as: HYpofractionateD RadioAblative

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What researchers measure

Primary outcomes

  1. toxicities

    Number of participants with acute related serious adverse events

    Time frame: 90 days

Secondary outcomes

  1. adverse events

    Number of participants with adverse events

    Time frame: 2 years

  2. quality of life

    Scale of quality of life questionnaire

    Time frame: 5 years

  3. disease control

    Number of participants with disease control (no evidence of disease, progression)

    Time frame: 5 years

  4. dosimetric improvement

    Scores of radiation quality review

    Time frame: 2 weeks

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Study locations

1 site
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02464137
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
Jun 8, 2015
Start date
Apr 27, 2015
Primary completion
Mar 4, 2019
Completion
Mar 4, 2019
Last update
Aug 20, 2020

Study contacts

Lucien Nedzi, MD
principal investigator · UTSW Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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