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INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy

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ClinicalTrials.gov Identifier: NCT03953976
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
In this study, the elective neck was treated to 40 Gray (Gy) (rather than the typical 56-60 Gy), and nodal levels were entired spared radiotherapy if more than 1 echleon away from malignant lymphadenopathy. Thus far there have been no elective nodal recurrences.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiation: Intensity modulated radiation therapy (IMRT) Phase 2

Detailed Description:
It is notable that the majority of disease sites treated with radiotherapy no longer receive elective/prophylactic radiotherapy to clinically-negative areas, including lung, pancreas, and lymphoma. Indeed, as will be discussed, these disease sites now employ involved nodal radiotherapy, or INRT, focusing on involved lymphadenopathy. In this study, we aim to improve acute and long-term toxicity of IMRT for OPC, LXC and hypopharyngeal cancer (HPX) by delivering INRT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INRT- AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy Using Artificial Intelligence-Based Radiomics for Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PET-CT at 3 months and ENT evaluation
Restaging PET-CT must be performed between 11-14 weeks from the completion of treatment. The patient must see an otolaryngologist after the PET-CT to decide on post-treatment neck dissection per the surgeon's judgement. Patients will then be seen every 3 months (+/- 2 weeks) for the first year, and then at least every 6 months (+/-2 weeks) until the 36 month. Subsequent and intervening follow-up visits will be made per physician preference
Radiation: Intensity modulated radiation therapy (IMRT)
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel). 6.5-7 weeks of radiotherapy or chemoradiotherapy




Primary Outcome Measures :
  1. Crude risk of solitary elective volume recurrence (SEVR) following INRT, according to NCI's CTCAE v4.0 toxicity criteria. [ Time Frame: 2 years ]
    Comparison of SEVR risks by p16 status and anatomic site


Secondary Outcome Measures :
  1. EORTC QLQ-C30 Summary score [ Time Frame: 36 months ]
    The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales. Patients rate overall health and quality of life.

  2. EORTC QLQ-C30 Physical and role functioning subscales [ Time Frame: 36 months ]
    Patients rate overall health and quality of life.

  3. EORTC HN35 Dry mouth and sticky saliva subscales [ Time Frame: 36 months ]
    Patients report to which extent they experience symptoms or problems during one week.

  4. MDADI global, emotional, functional and physical subscales [ Time Frame: 36 months ]
    Questionnaire asks for views about swallowing ability.

  5. EQ-5D global score (0-100) [ Time Frame: 36 months ]
    Patients describe health for current day regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
  2. Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable.
  3. Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
  4. Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
  5. Age ≥ 18 years.
  6. ECOG Performance Status 0-2
  7. 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

    7.1 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).
  8. Negative serum pregnancy test within 2 weeks before registration for women of childbearing potential.
  9. Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
  10. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. Distant metastasis.
  2. Inability to undergo PET-CT.
  3. Stage I and II glottic carcinoma.
  4. Gross total excision of both the primary and nodal disease.
  5. Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, 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 systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
  8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  9. Subjects may not be receiving any other investigational agents.
  10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
  11. 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
  12. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  13. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

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): NCT03953976


Contacts
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Contact: Kimberly Williams, MPH 214-648-1821 KimberlyA.Williams@UTSouthwestern.edu
Contact: Sarmistha Sen, MHA 214-645-1477 Sarmistha.Sen@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: David J Sher, MD, MPH UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03953976     History of Changes
Other Study ID Numbers: STU 2019-0711
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: May 2019
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
Product Manufactured in and Exported from the U.S.: No

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