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

January 2, 2019 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment (SBRT)

Participants 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SBRT
Device: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
Device: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of Head and Neck SBRT
Time Frame: 3 months
Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.
3 months
Incidence of Dose Limiting Toxicities (DLTs)
Time Frame: 3 months from start of treatment
Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0
3 months from start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 12 months
Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup
Up to 12 months
Local Progression Free Survival
Time Frame: Up to 12 months
Kaplan-Meier estimates will be used to plot local progression free survival.
Up to 12 months
Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
Time Frame: Up to 12 months
Trend tests will be used to investigate the relationship between SBRT dose and response.
Up to 12 months
Incidence of SBRT Related Morbidity
Time Frame: Up to 12 months
Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0
Up to 12 months
Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
Time Frame: Up to 12 months
Repeated analysis of variance measures will be used to analyze the quality of life data.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shlomo Koyfman, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2015

Primary Completion (ACTUAL)

February 6, 2017

Study Completion (ACTUAL)

February 6, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE8314
  • P30CA043703 (U.S. NIH Grant/Contract)
  • NCI-2014-02279 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CASE 8314 (OTHER: Case Comprehensive Cancer Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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