Malignant Neoplasms of Respiratory and Intrathoracic OrgansPhase 1NCT03114462
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
A Phase 1 study testing Stereotactic Hypofractionated Radioablation and Questionnaires in people with Malignant Neoplasms of Respiratory and Intrathoracic Organs and Squamous Cell Carcinoma of the Larynx, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Respiratory and Intrathoracic Organs, Squamous Cell Carcinoma of the Larynx
- What is being tested?
- Stereotactic Hypofractionated Radioablation and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 1 Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
- Stage T1N1/T2-4aN0-1 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. 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.
- 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.
- 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).
- Ability to understand English language and the willingness to sign a written informed consent.
Who cannot join
- 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.
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- Patients unable or unwilling to give written, informed consent.
- 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.
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Jack Phan, MD,PHD, jphan@mdanderson.org
Jack Phan, MD,PHD
About this study
Official title: A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
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.
Read the detailed description
Study Groups:
If participant is found to be eligible to take part in this study, participant will be assigned to a radiation level of HYDRA radiation based on when participant joins this study. Up to 5 dose levels of HYDRA radiation will be tested. Up to 10 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HYDRA radiation is found.
HYDRA Radiation Administration:
If participant is found to be eligible to take part in this study, participant will receive HYDRA radiation on up to 5 days over the course of about 2 weeks.
During radiation, participant will be asked to lie still for about 30-45 minutes. To help make sure that participant's head and neck do not move, participant will wear a head and neck mask. Participant will then have CT or PET-CT scans to make sure that participant is in the right position before participant begins HYDRA radiation. The actual HYDRA radiation treatment will take about 5-10 minutes to complete.
Length of Study Participation:
Participant may continue receiving HYDRA radiation for up to 2 weeks and for a total of 5 times. Participant will no longer be able to receive the study radiation if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
Participation on this study will be over after Long-Term Follow-Up. Long-Term Follow-Up may take up to 10 years.
Study Visits:
On Days that participant receives HYDRA:
- Participant will have a speech pathology exam to check participant's voice, swallowing, and breathing function.
- Participant will complete the same 5 questionnaires that participant did at screening.
Follow-Up Visits:
About 6 weeks after participant's last dose of HYDRA radiation:
- Participant will have a physical exam.
- Participant will have a videostroboscopy to check the status of the disease.
- Participant will have a speech pathology exam.
- Participant will have a CT or PET-CT scan to check the status of the disease.
- Participant will complete the same 5 questionnaires that participant did at screening.
- If the doctor thinks it is needed, participant will have a laryngoscopy to check the status of the disease. A laryngoscopy is a standard procedure in which a tube with a lighted camera is inserted through participant's mouth and into participant's throat.
- If the doctor thinks it is needed, participant will have a core biopsy to check the status of the disease. To perform a core biopsy, a sample of tissue is removed using a hollow core needle that has a cutting edge.
About 3 months after participant's last dose of HYDRA radiation:
- Participant will have a physical exam.
- Participant will have a modified barium swallow to test participant's swallowing function and to check the status of the disease.
- Participant will have a CT or PET-CT scan to check the status of the disease.
- Participant will complete the same 5 questionnaires that participant did at screening.
- If the doctor thinks it is needed, participant will have a laryngoscopy to check the status of the disease.
- If the doctor thinks it is needed, participant will have a core biopsy to check the status of the disease.
About 6 months after participant's last dose of HYDRA radiation:
- Participant will have a physical exam.
- Participant will have a videostroboscopy to check the status of the disease.
- Participant will complete the same 5 questionnaires that participant did at screening.
- If the doctor thinks it is needed, participant will have a CT or PET-CT scan to check the status of the disease.
- If the doctor thinks it is needed, participant will have a speech pathology exam.
- If the doctor thinks it is needed, participant will have a laryngoscopy to check the status of the disease.
- If the doctor thinks it is needed, participant will have a core biopsy to check the status of the disease.
Long-Term Follow-Up:
After participant's 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:
- Participant will have a physical exam.
- Participant will have a videostroboscopy to check the status of the disease.
- Participant will have a speech pathology exam.
- Participant will have a modified barium swallow to test participant's swallowing function and to check the status of the disease. This will only be done between 3-6 months and then 18-24 months after the first HYDRA dose.
- Participant will complete the same 5 questionnaires that participant did at screening.
- If the doctor thinks it is needed, participant will have a CT or PET-CT scan to check the status of the disease.
- If the doctor thinks it is needed, participant will have a laryngoscopy to check the status of the disease.
- If the doctor thinks it is needed, participant will have a core biopsy to check the status of the disease.
This is an investigational study. HYDRA radiation is delivered using methods that are not FDA-approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the radiation is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Malignant Neoplasms of Respiratory and Intrathoracic Organs, Squamous Cell Carcinoma of the Larynx
- Being tested
- Stereotactic Hypofractionated Radioablation, Questionnaires
- Keywords
- Malignant neoplasms of respiratory and intrathoracic organs, Squamous cell carcinoma of the larynx, Stereotactic hypofractionated radioablation, HYDRA, Questionnaires, Surveys
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Hypofractionated RadioablationRadiation
Also called HYDRA
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.
QuestionnairesBehavioural
Also called Surveys
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 group | Role | What they receive |
|---|---|---|
| Stereotactic Hypofractionated Radioablation (HYDRA) | Experimental | 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. Receives: Radiation: Stereotactic Hypofractionated Radioablation; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
Toxicity graded using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.0.
Measured: 180 days
Secondary outcomes (1)
Overall Complete Response Rate of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
Overall complete response rate with laryngeal HYDRA measured from duration of time from start of treatment to primary disease relapse.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start9 Aug 2017
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Respiratory and Intrathoracic OrgansStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Jack Phan, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114462
- Sponsor's protocol ID
- 2016-1023
- Other IDs
- NCI-2018-01164
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2017
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No