Clinical trial NCT02388932: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Head and Neck SBRT
timeFrame: 3 months
measure: Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: 3 months from start of treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 12 months
measure: Local Progression Free Survival
timeFrame: Up to 12 months
measure: Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
timeFrame: Up to 12 months
measure: Incidence of SBRT Related Morbidity
timeFrame: Up to 12 months
measure: Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Shlomo Koyfman
role: PRINCIPAL_INVESTIGATOR
References: