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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875716
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Danielle Margalit, MD, MPH, Dana-Farber Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Radiation therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of De-Intensified Risk-Adapted Postoperative Radiation Therapy for Human Papilloma Virus Associated Oropharyngeal Squamous Cell Carcinoma
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2027

Arm Intervention/treatment
No Intervention: Low Risk
  • Pathologic 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
Experimental: Intermediate Risk
  • Pathologic 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
Radiation: Radiation therapy
Radiation therapy

Experimental: High Risk
  • Pathologic T1-4N0-2 and any one of the following features:

    ->1mm extranodal extension

  • Microscopic positive margins
  • Adjuvant radiation therapy without chemotherapy
Radiation: Radiation therapy
Radiation therapy




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 2 years ]
    Survival without any signs or symptoms of cancer after the treatment ends.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    The length of time from the start of treatment until death.

  2. Toxicity Rate [ Time Frame: 2 years ]
    Adverse events experienced by the participants.

  3. Quality Of Life Questionnaire [ Time Frame: 2 Years ]
    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).

  4. Symptom burden: [ Time Frame: 2 years ]
    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)

  5. Dysphagia [ Time Frame: 2 Years ]
    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)

  6. Shoulder dysfunction [ Time Frame: 2 Years ]
    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")



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875716


Contacts
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Contact: Danielle N. Margalit, MD, MPH 617-632-6817 dmargalit@lroc.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02062
Contact: Danielle N. Margalit, MD, MPH    617-632-6817    dmargalit@lroc.harvard.edu   
Principal Investigator: Damielle N. Margalit, MD, MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Danielle N. Margalit, MD, MPH Dana-Farber Cancer Institute
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Responsible Party: Danielle Margalit, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03875716    
Other Study ID Numbers: 19-009
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication.
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell