Clinical Trials /

Study of Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

NCT03875716

Description:

This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
  • Tongue Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Study of Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
  • Official Title: A Phase 2 Study of De-Intensified Risk-Adapted Postoperative Radiation Therapy for Human Papilloma Virus Associated Oropharyngeal Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 19-009
  • NCT ID: NCT03875716

Conditions

  • Head and Neck Cancer

Purpose

This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.

Detailed Description

      This research study is being done to study if less intensive treatments can be used after
      surgery for head and neck cancers that are due to the human papilloma virus (HPV). In
      general, these cancers have better cure rates than other types of head and neck cancers.
      Therefore, the investigators are studying whether we can safely reduce the amount of
      treatment after surgery, such as surveillance (instead of using radiation) or less radiation
      or less chemotherapy, while maintaining good cure rates. The investigators hope that by
      reducing the intensity of treatment, this will lead to less side effects during and after
      cancer treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Low RiskNo InterventionPathologic T1-2, N0-1 Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck -≤2 positive lymph nodes confined to level II and/or level III No extranodal extension Clear margins
    Intermediate RiskExperimentalPathologic T1-2N0-2 and any one of the following features: ->2 positive lymph nodes <15 lymph nodes retrieved on neck dissection for each side of the neck Positive lymph nodes in level IB, IV, or V -≤1mm extranodal extension Positive lymph node(s) contralateral to the primary tumor Close margins Reduced-dose adjuvant radiation therapy
      High RiskExperimentalPathologic T1-4N0-2 and any one of the following features: ->1mm extranodal extension Microscopic positive margins Adjuvant radiation therapy without chemotherapy

        Eligibility Criteria

                Inclusion Criteria:
        
                  -  Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or
                     base of tongue (oropharynx)
        
                  -  HPV-associated tumor as defined by: positive p16 immunohistochemistry (>70%) OR in
                     situ hybridization OR PCR-based methods
        
                  -  Eligible for curative-intent surgery with anticipated negative margins
        
                  -  Surgery performed at Brigham & Women's Hospital
        
                  -  Age 18 or older years.
        
                  -  ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A)
        
                  -  Normal organ and marrow function as defined below:
        
                       -  leukocytes ≥3,000/mcL
        
                       -  absolute neutrophil count ≥1,000/mcL
        
                       -  platelets ≥100,000/mcL
        
                       -  total bilirubin within normal institutional limits
        
                       -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
        
                       -  creatinine ≤ 1.5 times the institutional upper limit of normal OR
        
                       -  creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels
                          above institutional normal.
        
                  -  Patients with ≤10 pack-years of cumulative cigarette smoking. Pack-years are
                     calculated by multiplying the number of years smoked with the pack of cigarettes
                     smoked per day. One pack is considered to contain 20 cigarettes.
        
                  -  Tumor clinical stage (AJCC 8th edition): T1 or T2
        
                  -  Nodal clinical stage (AJCC 8th edition): N0 or N1
        
                  -  No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition).
        
                  -  Ability to understand and the willingness to sign a written informed consent document.
        
                Exclusion Criteria:
        
                  -  Prior history of head and neck cancer within 5 years.
        
                  -  Prior head and neck radiation
        
                  -  Clinically fixed or matted nodes
        
                  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
                     infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
                     arrhythmia, or psychiatric illness/social situations that would limit compliance with
                     study requirements. Note: that HIV positive patients will be eligible.
        
                  -  Pregnant women are excluded from this study because of the teratogenic risks of
                     radiation exposure to the developing fetus. Because there is an unknown but potential
                     risk for adverse events in nursing infants secondary to treatment of the mother with
                     radiation therapy and supportive care medications required for symptomatic management
                     of head and neck cancer side effects as well as general anesthesia required for
                     oncologic head and neck surgery, breastfeeding should be discontinued if the mother is
                     enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Disease-free survival
        Time Frame:2 years
        Safety Issue:
        Description:Survival without any signs or symptoms of cancer after the treatment ends.

        Secondary Outcome Measures

        Measure:Overall Survival
        Time Frame:2 years
        Safety Issue:
        Description:The length of time from the start of treatment until death.
        Measure:Toxicity Rate
        Time Frame:2 years
        Safety Issue:
        Description:Adverse events experienced by the participants.
        Measure:Quality Of Life Questionnaire
        Time Frame:2 Years
        Safety Issue:
        Description:Assesses the physical; social/family; emotional and functional wellbeing, using Functional Assessment of Cancer Therapy for Head and Neck (FACT-H&N) on a scale of 0-4 (where 0 indicates the lowest quality of life and 4 indicates the highest quality of life).
        Measure:Symptom burden:
        Time Frame:2 years
        Safety Issue:
        Description:Patient-reported symptom severity, using M.D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) on a scale of 0-10 (where 0 indicates symptom is not present and 10 indicates the symptom is as bad as can be)
        Measure:Dysphagia
        Time Frame:2 Years
        Safety Issue:
        Description:Swallowing ability or difficulty. Dysphagia-related quality of life, assessed with the MD Anderson Dysphagia Inventory (MDADI) on a scale of 1-5 (where 1 indicates the patient strongly agrees and 5 indicates the patient strongly disagrees)
        Measure:Shoulder dysfunction
        Time Frame:2 Years
        Safety Issue:
        Description:Shoulder function or dysfunction is measured with the "neck dissection impairment index" (NDII). This evaluates how much the patient's neck and/or shoulder affects them as a result of the treatment they received in their neck during the overall management of their cancer. This scale goes from 1-5 (1 being "not at all" and 5 being "a lot")

        Details

        Phase:N/A
        Primary Purpose:Interventional
        Overall Status:Not yet recruiting
        Lead Sponsor:Dana-Farber Cancer Institute

        Last Updated