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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 : November 29, 2017
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Behavioral: Questionnaires
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
  2. Stage T1N1/T2-4aN0-1 disease, as defined by American Joint Committee on Cancer (AJCC) criteria.
  3. ECOG (Zubrod) performance status 0-2.
  4. Must be functionally and technically fit for partial laryngectomy. Subsite study candidates will be evaluated by enrolling physician. The assessment checklist will be submitted at time of enrollment and evaluated by Dr. Gross or Dr. Phan.
  5. 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  6. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: *Has not undergone a hysterectomy or bilateral oophorectomy; or *Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  7. Ability to understand English language and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. Patients who have undergone resection of primary disease.
  2. Patients who have received induction chemotherapy for their cancer diagnosis.
  3. 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.
  4. Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
  5. Prior radiation therapy to the head and neck region.
  6. 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.
  7. Patients unable or unwilling to give written, informed consent.
  8. Severe, active co-morbidity, defined as follows: a. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. b. Transmural myocardial infarction within the last 6 months. c. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. d. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration. e. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and f. 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.
  9. Exclusion #8 continued: g. History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.
  10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
  11. Evidence of metastatic disease

Information from the National Library of Medicine

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


Contacts
Contact: Jack Phan, MD, PHD 713-563-2300 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cancer Prevention Research Institute of Texas
Investigators
Principal Investigator: Jack Phan, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03114462     History of Changes
Other Study ID Numbers: 2016-1023
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of respiratory and intrathoracic organs
Squamous cell carcinoma of the larynx
Stereotactic hypofractionated radioablation
HYDRA
Questionnaires
Surveys

Additional relevant MeSH terms:
Laryngeal Diseases
Carcinoma, Squamous Cell
Laryngeal Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases