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 : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Radiation: Intensity modulated radiation therapy (IMRT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- EORTC QLQ-C30 Physical and role functioning subscales [ Time Frame: 36 months ]Patients rate overall health and quality of life.
- 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.
- MDADI global, emotional, functional and physical subscales [ Time Frame: 36 months ]Questionnaire asks for views about swallowing ability.
- 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.
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
|Contact: Kimberly Williams, MPH||214-648-1821||KimberlyA.Williams@UTSouthwestern.edu|
|Contact: Sarmistha Sen, MHA||214-645-1477||Sarmistha.Sen@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||David J Sher, MD, MPH||UT Southwestern Medical Center|