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

Primary Purpose

Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Positron Emission Tomography
Computed Tomography
Quality-of-Life Assessment
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Hypopharyngeal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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'.
Incidence of Dose Limiting Toxicities (DLTs)
Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0

Secondary Outcome Measures

Overall Survival
Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup
Local Progression Free Survival
Kaplan-Meier estimates will be used to plot local progression free survival.
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.
Incidence of SBRT Related Morbidity
Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0
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.

Full Information

First Posted
March 9, 2015
Last Updated
January 2, 2019
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02388932
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
March 3, 2015 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Squamous Cell Carcinoma, Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage III Oral Cavity Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IVA Hypopharyngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Squamous Cell Carcinoma, Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Hypopharyngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Squamous Cell Carcinoma, Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Hypopharyngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Squamous Cell Carcinoma, Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVC Oral Cavity Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SBRT
Intervention Description
Undergo SBRT
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Intervention Description
Undergo PET/CT
Intervention Type
Device
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, CT
Intervention Description
Undergo PET/CT
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Head and Neck SBRT
Description
Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.
Time Frame
3 months
Title
Incidence of Dose Limiting Toxicities (DLTs)
Description
Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0
Time Frame
3 months from start of treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup
Time Frame
Up to 12 months
Title
Local Progression Free Survival
Description
Kaplan-Meier estimates will be used to plot local progression free survival.
Time Frame
Up to 12 months
Title
Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
Description
Trend tests will be used to investigate the relationship between SBRT dose and response.
Time Frame
Up to 12 months
Title
Incidence of SBRT Related Morbidity
Description
Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0
Time Frame
Up to 12 months
Title
Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
Description
Repeated analysis of variance measures will be used to analyze the quality of life data.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomo Koyfman
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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