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HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT04403620
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
Dominic Moon, University of Texas Southwestern Medical Center

Brief Summary:
There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Radiation: Intensity-modulated Radiation Therapy (IMRT) Phase 1 Phase 2

Detailed Description:
The trial will assess the effects of aggressive hypofractionated radiation therapy in patients with oral cavity, oropharynx, hypopharynx, or larynx cancer after surgical resection with pathology showing intermediate risk factors requiring post-operative radiation therapy without concurrent chemotherapy. During Phase 1, the maximum tolerated dose/fractionation and tolerability will be determined. During Phase 2, patients will be randomized between conventionally fractionated radiation therapy (6 weeks) vs. hypofractionated radiation therapy (3 weeks) to establish non-inferiority of hypofractionated radiation therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose/fractionation finding Phase 1 study, followed by a randomized Phase 2 study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventionally fractionated radiotherapy
60 Gy in 30 fractions, 5 fractions/week
Radiation: Intensity-modulated Radiation Therapy (IMRT)
Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection

Experimental: Hypofractionated radiotherapy

Dose and fractionation determined by Phase I:

Level 1: 44.4 Gy in 12 fractions, 4 fractions/week

Level 0: 46.5 Gy in 15 fractions, 5 fractions/week

Level -1: 52 Gy in 20 fractions, 5 fractions/week

Level -2: 50 Gy in 20 fractions, 5 fractions/week

Radiation: Intensity-modulated Radiation Therapy (IMRT)
Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection




Primary Outcome Measures :
  1. Phase 1: Maximally tolerated dose of hypofractionated radiation therapy [ Time Frame: 3 months ]
    Dose and fractionation to be used for Phase 2

  2. Phase 2: Swallowing-related patient-reported quality of life [ Time Frame: 12 months ]
    MD Anderson Dysphagia Inventory (MDADI) composite score: 20-100, higher scores mean better quality of life


Secondary Outcome Measures :
  1. Clinician-reported acute toxicities [ Time Frame: 1-3 months ]
    CTCAE v5.0

  2. Clinician-reported late toxicities [ Time Frame: 6-24 months ]
    CTCAE v5.0

  3. Locoregional control [ Time Frame: 12-24 months ]
  4. Progression free survival [ Time Frame: 12-24 months ]
  5. Swallowing-related patient-reported quality of life [ Time Frame: 1-24 months ]
    MD Anderson Dysphagia Inventory (MDADI): 20-100, higher scores mean better quality of life

  6. Head and neck patient-reported quality of life [ Time Frame: 1-24 months ]
    University of Washington QOL questionnaire (UW-QOL): 0-100, higher scores mean better quality of life

  7. Xerostomia-related patient-reported quality of life [ Time Frame: 1-24 months ]
    University of Michigan Xerostomia questionnaire (XQ): 0-100, higher scores mean worse quality of life

  8. General patient-reported quality of life [ Time Frame: 1-24 months ]
    EuroQol-5 dimensions (EQ-5D-5L): 1-5, higher scores mean worse quality of life

  9. Feeding tube dependence [ Time Frame: 1-24 months ]
    Feeding tube dependence defined as daily use of the feeding tube with ≥2 nutritional supplements (e.g. Ensure, Boost, etc.) per day at the time of enrollment on trial



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
Criteria

Inclusion Criteria:

Inclusion criteria will be the same for Phase I and Phase II.

  1. Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx status post gross total resection with pathology showing one or more of the following intermediate risk factors:

    • T3/4 disease (AJCC 8th edition), positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion
    • Close margin(s) defined as either:

      • Final patient margin of <5 mm without disease on ink OR
      • Initial positive margin in the specimen regardless of the final patient margin (e.g. if resection margin on the initial specimen is positive, final patient margin after subsequent resections can be ≥5 mm and still be considered close margin)
  2. Age ≥18 years
  3. ECOG performance status 0-2
  4. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

    Medically acceptable birth control (contraceptives) includes:

    • approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or
    • barrier methods (such as condom or diaphragm) used with a spermicide

    Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

    A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  5. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
  6. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Phase I:

  1. Distant metastasis
  2. Stage I and II glottic squamous cell carcinoma
  3. High risk factors following surgical resection requiring concurrent chemotherapy: final positive margin(s) and/or extranodal extension
  4. Feeding tube dependence at baseline assessment.
  5. Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after treatment, provided all other eligibility criteria are met.
  6. Prior invasive malignancy with an expected disease-free interval of less than 3 years
  7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
  8. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
  9. 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, in the opinion of the investigator, would limit compliance with study requirements
  10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  11. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant

Phase II:

The exclusion criteria will be the same as Phase I except for feeding tube dependence. Patients who are feeding tube dependent are excluded from Phase I to accurately assess treatment associated toxicity affecting swallowing and oral intake. During Phase II, patients who are feeding tube dependent will be eligible to enroll and stratified at randomization.


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): NCT04403620


Contacts
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Contact: Sarah Neufeld, MS 214-645-8525 sarah.hardee@utsouthwestern.edu
Contact: Kajal Desai, MS kajal.desai@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Dominic Moon, MD UT Southwestern Medical Center
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Responsible Party: Dominic Moon, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04403620    
Other Study ID Numbers: STU 2020-0522
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: March 2023

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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 Dominic Moon, University of Texas Southwestern Medical Center:
Radiation Dose Hypofractionation
Adjuvant Radiotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site