HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer

NCT02464137 | Terminated Phase 1 DMC

• 1 other identifier: STU 052014-085
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Larynx

Outcome Measures

Primary Outcomes (1)

• toxicities

  Number of participants with acute related serious adverse events

  90 days

Secondary Outcomes (4)

• adverse events

  2 years

• quality of life

  5 years

• disease control

  5 years

• dosimetric improvement

  2 weeks

Study Arms (1)

Radiation

EXPERIMENTAL

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

radiation 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.

Also known as: HYpofractionateD RadioAblative

Radiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
• Transmural myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
• 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.
• 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.
• History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Lucien Nedzi, MD

  UTSW Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: June 8, 2015
• Study Start: April 27, 2015
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-03

Locations

US (1)