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Recurrent Hypopharyngeal Squamous Cell CarcinomaNCT02388932

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer

A study testing Stereotactic Body Radiation Therapy, Positron Emission Tomography and Computed Tomography in people with Recurrent Hypopharyngeal Squamous Cell Carcinoma and Recurrent Laryngeal Squamous Cell Carcinoma, run by Case Comprehensive Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic Body Radiation Therapy, Positron Emission Tomography and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
3 Mar 2015to 6 Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • The participant must have squamous cell carcinoma proven by histologic diagnosis; for cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16 staining is not required
  • The participant must have clinical stage T1-4, N0-3, M0-1, stage II-IVC carcinoma as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging manual; participants with T1N0M0 will be ineligible; participants with metastatic disease with a limited metastatic burden are eligible if obtaining local control is determined by their treating oncologist to be an important therapeutic goal
  • The participant must have imaging documenting a primary tumor, or involved lymph node, ≥ 2.5 cm in greatest dimension
  • PET/CT is required for all participants, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to SBRT planning
  • The participant must have a history and physical documented within four weeks of registration and be deemed by a medical oncologist to be ineligible for standard continuous course chemoradiotherapy with cisplatin
  • Karnofsky performance status (PS) ≥ 40
  • Female participants cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months
  • Participants must have the ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Participants with T1N0M0 stage I disease
  • Participants who are receiving any other investigational agents
  • Participants with non-squamous cell histology
  • Participants with life expectancy < 6 months
  • Participants who cannot lie flat for 20 minutes
  • Participants with prior history of head and neck radiotherapy (> 40 Gy) with significant areas of anticipated overlap

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase I Dose Escalation Study of Stereotactic Body Radiotherapy for Carcinoma of the Head and Neck in High Risk Patients Who Are Ineligible/Refuse Standard of Care Therapy

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk participant population ineligible for standard chemoradiotherapy.

SECONDARY OBJECTIVES:

  1. Assess profiles of SBRT toxicity and examine participant (including co-morbidities), tumor and treatment related factors that are associated with SBRT related toxicity.

II. Identify any dose volume parameters that are associated with SBRT related toxicity.

III. Explore potential dose response relationships between higher SBRT dosing and radiographic response.

IV. Assess impact of SBRT on participants' quality of life.

OUTLINE: This is a dose-escalation study.

Participants undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.

After completion of study treatment, participants are followed up at 0.5, 3, 6, 9, and 12 months.

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.

Study groups in NCT02388932
Study groupRoleWhat they receive
Treatment (SBRT)ExperimentalParticipants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Receives: Radiation: Stereotactic Body Radiation Therapy; Device: Positron Emission Tomography; Device: Computed Tomography; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of Head and Neck SBRT

    Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.

    Measured: 3 months

  2. Incidence of Dose Limiting Toxicities (DLTs)

    Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0

    Measured: 3 months from start of treatment

Secondary outcomes (5)

  1. Overall Survival

    Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup

    Measured: Up to 12 months

  2. Local Progression Free Survival

    Kaplan-Meier estimates will be used to plot local progression free survival.

    Measured: Up to 12 months

  3. Response Measured According to Standard Response Evaluation Criteria in Solid Tumors

    Trend tests will be used to investigate the relationship between SBRT dose and response.

    Measured: Up to 12 months

  4. Incidence of SBRT Related Morbidity

    Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0

    Measured: Up to 12 months

  5. Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire

    Repeated analysis of variance measures will be used to analyze the quality of life data.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study start3 Mar 2015
  3. Primary completion6 Feb 2017
  4. Study completion6 Feb 2017

Why it stopped: Slow Accrual

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388932
Sponsor's protocol ID
CASE8314
Other IDs
NCI-2014-02279, CASE8314, CASE 8314, P30CA043703
Status last verified
Jan 2019
First submitted
9 Mar 2015
Last updated
24 Jan 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Body Radiation Therapy, Positron Emission Tomography and Computed Tomography in people with Recurrent Hypopharyngeal Squamous Cell Carcinoma and Recurrent Laryngeal Squamous Cell Carcinoma, run by Case Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Head and Neck SBRT (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02388932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.

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