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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03953976
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensity modulated radiation therapy (IMRT) — RADIATION
    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

Study Details

Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.

Key Dates

Start date
Jul 23, 2019
Status verified
Oct 2025
Primary completion
Nov 15, 2022
Completion
Jan 22, 2024

Study Design

Enrollment
67 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PET-CT at 3 months and ENT evaluation
    Treatment to the gross primary and nodal disease (70 Gy), with suspicious nodes treated to 66.5 Gy, all in 35 fractions. CT and PET-CT are required for nodal assessment. 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

Primary Outcome Measure

Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical Center - DallasDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Texas Southwestern Medical Center - Dallas· Dallas, TX

Related Studies