INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy (NCT03953976) | Clinical Trial Compass
CompletedPhase 2
INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
United States67 participantsStarted 2019-07-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
✓. 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.
✓. Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
✓. Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
✓. Age ≥ 18 years.
✓. ECOG Performance Status 0-2
✓. 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.
✓.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:
Exclusion criteria
✕. Distant metastasis.
✕. Inability to undergo PET-CT.
✕
What they're measuring
1
Risk of Solitary Elective Volume Recurrence Following Elective Volume Reduction Using INRT
Timeframe: 2 years
Trial details
NCT IDNCT03953976
SponsorUniversity of Texas Southwestern Medical Center
✕. Gross total excision of both the primary and nodal disease.
✕. 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 .
✕. Prior invasive malignancy with an expected disease-free interval of less than 3 years.
✕. Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
✕. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.