Recurrent Laryngeal Squamous Cell Carcinoma Clinical Trial
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
Verified date | January 2019 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | February 6, 2017 |
Est. primary completion date | February 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Overall Survival | Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup | Up to 12 months | |
Secondary | Local Progression Free Survival | Kaplan-Meier estimates will be used to plot local progression free survival. | Up to 12 months | |
Secondary | 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. | Up to 12 months | |
Secondary | Incidence of SBRT Related Morbidity | Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0 | Up to 12 months | |
Secondary | 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. | Up to 12 months |
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