Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02388932
Other study ID # CASE8314
Secondary ID NCI-2014-02279CA
Status Terminated
Phase N/A
First received
Last updated
Start date March 3, 2015
Est. completion date February 6, 2017

Study information

Verified date January 2019
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • 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

Intervention

Radiation:
Stereotactic Body Radiation Therapy
Undergo SBRT
Device:
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Other:
Quality-of-Life Assessment
Ancillary studies

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03468218 - Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer Phase 2
Recruiting NCT04862650 - Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 2
Completed NCT01256385 - Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy Phase 2
Completed NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer N/A
Recruiting NCT04754321 - Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer Phase 1
Terminated NCT02196168 - Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Recruiting NCT05063552 - Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers Phase 2/Phase 3
Recruiting NCT04588038 - NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery Phase 1
Active, not recruiting NCT04576091 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer Phase 1
Recruiting NCT05172258 - Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck Phase 2
Active, not recruiting NCT02007200 - Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery Phase 2
Completed NCT01064479 - Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 2
Completed NCT00458978 - Cediranib Maleate in Treating Patients With Recurrent or Newly Diagnosed Metastatic Head and Neck Cancer Phase 2
Completed NCT01254617 - Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer Phase 1
Active, not recruiting NCT01267240 - Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Phase 2
Active, not recruiting NCT00588770 - Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 3
Recruiting NCT04671667 - Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT00494182 - Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer Phase 2
Terminated NCT02068157 - Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer Phase 2