Study Stopped
Slow Accrual
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
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
4 other identifiers
interventional
3
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2015
CompletedFirst Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2017
CompletedResults Posted
Study results publicly available
November 16, 2018
CompletedJanuary 24, 2019
January 1, 2019
1.9 years
March 9, 2015
October 15, 2018
January 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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'.
3 months
Incidence of Dose Limiting Toxicities (DLTs)
Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0
3 months from start of treatment
Secondary Outcomes (5)
Overall Survival
Up to 12 months
Local Progression Free Survival
Up to 12 months
Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
Up to 12 months
Incidence of SBRT Related Morbidity
Up to 12 months
Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
Up to 12 months
Study Arms (1)
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.
Interventions
Undergo PET/CT
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to slow accrual the study was terminated early.
Results Point of Contact
- Title
- Shlomo Koyfman, MD
- Organization
- Cleveland Clinic, Case Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Shlomo Koyfman
Case Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 17, 2015
Study Start
March 3, 2015
Primary Completion
February 6, 2017
Study Completion
February 6, 2017
Last Updated
January 24, 2019
Results First Posted
November 16, 2018
Record last verified: 2019-01