Endurant Evo US Clinical Trial

Brief Title

Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

Official Title

A Non-Randomized, Open-Label, Multi-Center Pilot Study Evaluating Hypofractionation Radiation Therapy in Head and Neck Squamous Cell Carcinoma

Brief Summary

      The purpose of this research study is to investigate a shorter radiation treatment schedule
      for head and neck cancers in patients 70 years of age and older.

      Standard radiation treatment for head and neck patients normally requires that the patient
      travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week.
      This long course of radiation can lead to significant side effects resulting in some people
      being unable to complete the course of treatment. If this happens, and there are gaps in the
      radiation treatment, this can lead to worse outcomes.
    

Detailed Description

      This is a non-randomized pilot study examining the objective response rate and tolerability
      of short-course radiotherapy (RT) in elderly patients who are unfit for standard conventional
      fractionation treatment with head and neck squamous cell carcinoma (HNSCC). There will be two
      unrelated cohorts in this study: definitive RT and adjuvant RT. Patients will be assigned to
      the cohorts based on their surgical or non-surgical candidacy. The primary study measure is
      the locoregional control (LRC) rate of patients at 6 months post RT treated with short-course
      RT. Locoregional control at one year will be determined by radiographic (PET/CT) and clinical
      assessment of disease. For the definitive cohort, LRC will be defined as regression in size
      or disappearance of primary tumor and/or lymph nodes on imaging or clinical examination; and
      for the adjuvant cohort, LRC will be defined as absence of disease on imaging or no clinical
      evidence of disease.

      To further investigate the treatment regimen, the study team will assess the safety of
      short-course RT and determine the incidence of serious complications, overall survival (OS),
      disease-free survival (DFS) within 1 year, and the change in quality of life (QoL) in these
      patients who are unfit for standard conventional fractionation treatment with head and neck
      squamous cell carcinoma (HNSCC) as secondary objectives. Secondary endpoints will include 1-
      year overall survival (OS), 1-year disease-free survival (DFS), and the total score of the
      Functional Assessment of Cancer Therapy-Head and Neck questionnaire (FACT-H&N). DFS will be
      defined from the completion of treatment until disease recurrence locally, regionally and/or
      distantly or until death from disease. OS will be defined from the RT to death or to last
      follow-up.

      As a safety endpoint, the study team will calculate number and proportion of patients
      developing reportable AEs and SAEs according to relatedness to the treatment and stratified
      by severity.
    


Study Type

Interventional


Primary Outcome

Number of participants with Locoregional Control (LRC)

Secondary Outcome

 Overall Survival (OS) rate

Condition

Head and Neck Squamous Cell Carcinoma (HNSCC)

Intervention

Adjuvant hypofractionation

Study Arms / Comparison Groups

 Adjuvant Hypofractionated Radiation Treatment
Description:  Short course radiation therapy for patients who have undergone surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

40

Start Date

July 3, 2019

Completion Date

May 2024

Primary Completion Date

May 2024

Eligibility Criteria

        Inclusion Criteria

          -  Age ≥ 70 years.

          -  No previous RT or chemotherapy for HNSCC is allowed at time of study entry.

          -  Life expectancy > 12 weeks.

          -  Participants must have histologically or cytologically confirmed diagnosis of HNSCC:
             oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown
             primary)

          -  All stages (according to National Comprehensive Cancer Network 8th edition for head
             and neck cancers), except stage IVC5

          -  Non-concurrent chemotherapy

          -  First line treatment

          -  Anyone eligible for definitive or adjuvant based RT therapy

          -  Adjuvant therapy when histopathological factors (advanced T category, nodal disease,
             lymphovascular or perineural invasion, high-grade, or positive margins)

          -  Anyone being treated with curative intent

          -  Unfit as determined by the treating physician and ECOG performance 1, 2, or 3
             (Appendix 2).

          -  Ability to understand and the willingness to sign a written informed consent.

        Exclusion Criteria

          -  Patients < 70

          -  Metastatic disease outside of the head and neck

          -  Pregnancy

          -  Previous or current malignancies at other sites, with the exception of adequately
             treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin,
             thyroid cancer, or other cancer curatively treated by surgery and with no current
             evidence of disease for at least 5 years.

          -  Prior RT of head and neck area

          -  Concurrent chemotherapy or immunotherapy or hormonotherapy

          -  Any comorbid connective tissue disorder which could aggravate RT associated toxicities
             (e.g. Scleroderma)

          -  In cases where patients cannot consent on their own due to underlying dementia, we can
             consent the patient's healthcare proxy
      

Gender

All

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Richard L. Bakst, MD, (212) 241- 3545, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04284540

Organization ID

GCO 19-0499


Responsible Party

Principal Investigator

Study Sponsor

Icahn School of Medicine at Mount Sinai


Study Sponsor

Richard L. Bakst, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai


Verification Date

February 2020