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EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers

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: NCT03777384
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Sanford Health

Study Description
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Brief Summary:
A prospective, observational study evaluating the durability of local/regional control of previously published de-escalated radiotherapy protocols for patients with P16 positive oropharynx cancers who have minimal nicotine exposure who are not current uses (< 10 pack year smoking history; < 10 year history of any nicotine product [electronic cigarette, chewing tobacco]). Quality of Life measures will also be collected.

Condition or disease
Oropharyngeal Cancer

Detailed Description:

This is a prospective, single-site, observational study in head and neck cancer participants. The purpose of this study is to provide a systematic platform to analyze, interpret, and track radiation dose de-escalation therapy and associated participant outcomes from treatments identified by these results.

Participants will be asked to complete quality of life questionnaires at regular time points before, during, and after treatment.

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2023
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting. [ Time Frame: End of treatment to 5 years after end of treatment ]
    Number of participants who remain disease free from the end of treatment to 5 years after treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HPV positive oropharynx cancers who have minimal nicotine exposure who are not current uses (< 10 pack year smoking history; < 10 year history of any nicotine product [electronic cigarette, chewing tobacco]).
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Histologic confirmation of tumor of the oropharynx
  • Radiation therapy (de-escalated head and neck irradiation) decision has been made

  • Human Papilloma Virus (HPV) associated cancer as determined by positive p16 immunohistochemistry

    • HPV positivity is defined by p16 IHC staining of > 70% of tumor cells (strong and diffuse nuclear and cytoplasmic staining)
    • For cases that are indeterminate or if p16 testing cannot be accurately performed, HPV positivity can be confirmed by high-risk HPV DNA Testing which covers the following HPV subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
  • < 10 pack year smoking history OR < 10 year nicotine use history
  • No current tobacco/nicotine use (including electronic cigarettes and chewing tobacco)
  • T1-T3, N0-N2 (AJCC8) requiring definitive therapy greater than surgery alone
  • Ability to provide informed written consent
  • Willingness to return to Sanford Cancer Center for follow-up
  • Life expectancy > 12 weeks
  • ECOG performance status < 3 (Appendix B)
  • Adequate organ function for chemotherapy and radiotherapy

Exclusion Criteria:

  • Any of the following because the inclusion criteria require delivery of radiotherapy and chemotherapy which is known to be genotoxic, and is associated with mutagenic and teratogenic effects: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Prior head and neck radiotherapy
  • Any factor precluding safe delivery of chemotherapy
Contacts and Locations
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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): NCT03777384


Contacts
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Contact: Colette Free 605-312-3322 colette.free@sanfordhealth.org

Locations
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United States, North Dakota
Sanford Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58102
Contact: Brittany Bloch    701-234-7563    Brittany.Bloch@SanfordHealth.org   
Principal Investigator: Miran Blanchard, MD         
United States, South Dakota
Sanford Edith Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Jeanne Litka    605-312-3328    Jeanne.Litka@sanfordhealth.org   
Sponsors and Collaborators
Sanford Health
Investigators
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Study Chair: Miran Blanchard, MD Sanford Health
More Information
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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03777384    
Other Study ID Numbers: SH EVOLVE
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanford Health:
oropharynx
head and neck cancer
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases