INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT03953976|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 20, 2019
|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|
|Estimated Study Start Date :||July 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.
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|
|Principal Investigator:||David J Sher, MD, MPH||UT Southwestern Medical Center|