Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
NCT ID: NCT02388932
Last Updated: 2019-01-24
Study Results
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View full resultsBasic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2015-03-03
2017-02-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Stereotactic Body Radiation Therapy
Undergo SBRT
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Interventions
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Stereotactic Body Radiation Therapy
Undergo SBRT
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Shlomo Koyfman
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2014-02279
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE8314
Identifier Type: -
Identifier Source: secondary_id
CASE 8314
Identifier Type: OTHER
Identifier Source: secondary_id
CASE8314
Identifier Type: -
Identifier Source: org_study_id
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